treating schizophrenia in low and middle income (lami) countries: challenges and opportunities...

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Treating Schizophrenia in Low Treating Schizophrenia in Low And Middle Income (LAMI) And Middle Income (LAMI) Countries: Challenges and Countries: Challenges and opportunities opportunities Prof . Saeed Farooq, Prof . Saeed Farooq, Department of Psychiatry, Department of Psychiatry, Post Graduate Medical Post Graduate Medical Institute Lady Reading Institute Lady Reading Hospital, Hospital, Peshawar, PAKISTAN. Peshawar, PAKISTAN.

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Page 1: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Treating Schizophrenia in Low Treating Schizophrenia in Low And Middle Income (LAMI) And Middle Income (LAMI) Countries: Challenges and Countries: Challenges and opportunitiesopportunities

Prof . Saeed Farooq, Department of Prof . Saeed Farooq, Department of Psychiatry, Psychiatry, Post Graduate Medical Institute Lady Post Graduate Medical Institute Lady Reading Hospital,Reading Hospital,Peshawar, PAKISTAN.Peshawar, PAKISTAN.

Page 2: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The prevalence of psychotic disorders in The prevalence of psychotic disorders in LAMI. LAMI.

System of care for Chronic disorders System of care for Chronic disorders

Staging in Schizophrenia Staging in Schizophrenia

Page 3: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Duration of Untreated Psychosis (DUP) Duration of Untreated Psychosis (DUP) in LAMI, its relationship with the income in LAMI, its relationship with the income status and outcome of Schizophreniastatus and outcome of Schizophrenia

Early Intervention for Schizophrenia Early Intervention for Schizophrenia

Page 4: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Supervised Treatment in Outpatients for Supervised Treatment in Outpatients for Schizophrenia (STOPS): The concept Schizophrenia (STOPS): The concept and Randomised Controlled Trialand Randomised Controlled Trial

Research and Clinical Guidelines Research and Clinical Guidelines DevelopmentDevelopment

Page 5: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

ObjectivesObjectives

Critically examine the concept of ‘natural’ Critically examine the concept of ‘natural’

course of Schizophrenia course of Schizophrenia

To introduce the concept of Clinical To introduce the concept of Clinical staging in Schizophreniastaging in Schizophrenia

Page 6: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

ObjectivesObjectives

Discuss the Duration of Untreated Discuss the Duration of Untreated Psychosis (DUP), its correlates and Psychosis (DUP), its correlates and consequences in context of Low and consequences in context of Low and Middle Income CountriesMiddle Income Countries

To identify the opportunities for research To identify the opportunities for research and clinical practice development . and clinical practice development .

Page 7: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The challenge at Health The challenge at Health systems level systems level

Continuity of care and maintaining long Continuity of care and maintaining long term medication.term medication.

Page 8: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Challenge at individual Challenge at individual levellevel

Compliance/adherence with treatmentCompliance/adherence with treatment

Page 9: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Present level of Present level of untreated, partially untreated, partially treated casestreated cases

Unknown but must be close to 90%Unknown but must be close to 90%

Page 10: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Chronic conditions – Chronic conditions – Present system of carePresent system of care

Page 11: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:
Page 12: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Adherence with Adherence with Treatment in Treatment in SchizophreniaSchizophrenia

About 59% of patients may fail to adhere About 59% of patients may fail to adhere to their treatment.to their treatment.

CATIE Trial :1493 patients with follow up CATIE Trial :1493 patients with follow up for 18 months for 18 months

74 percent of patients discontinued the 74 percent of patients discontinued the medication before 18 months of the study medication before 18 months of the study period.period.

Page 13: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Adherence with Adherence with Treatment in Treatment in SchizophreniaSchizophrenia

With the exception of Olanzapine With the exception of Olanzapine ( discontinued by 64 percent ) atypical ( discontinued by 64 percent ) atypical antipsychotic did not fare better than the antipsychotic did not fare better than the typical antipsychotic ( 82 percent for typical antipsychotic ( 82 percent for quetiapine, 74 percent in risperidone, and quetiapine, 74 percent in risperidone, and 79 percent of those assigned to 79 percent of those assigned to ziprasidone could not continue the drug for ziprasidone could not continue the drug for trial period versus 75 percent of those trial period versus 75 percent of those assigned to Perphenazine)assigned to Perphenazine)

Page 14: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Non adherence to drugs in Non adherence to drugs in schizophreniaschizophrenia

Lack of insight Lack of insight Cultural beliefCultural belief Affects mostly poor people who can not afford Affects mostly poor people who can not afford

treatmenttreatment Chronic condition & needs continuity of careChronic condition & needs continuity of care Schizophrenia has stigma associated with it and Schizophrenia has stigma associated with it and

relatives and patients are reluctant to have treatment relatives and patients are reluctant to have treatment or seek help for this disorder. or seek help for this disorder.

. .

Page 15: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

What is the most important determinant What is the most important determinant of outcome in Schizophreniaof outcome in Schizophrenia

Page 16: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Duration of Untreated Duration of Untreated PsychosisPsychosis

Page 17: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Poor outcome for untreated Poor outcome for untreated schizophreniaschizophrenia

Co-morbid substance abuseCo-morbid substance abuse SuicideSuicide Increased treatment resistanceIncreased treatment resistanceImpairment in cognitive and neuropsychological Impairment in cognitive and neuropsychological functionsfunctions Offending behaviorOffending behaviorVocational failure Vocational failure Overall poor outcome. Each relapse in Overall poor outcome. Each relapse in schizophrenia results in additional costs and schizophrenia results in additional costs and miseries for the patientmiseries for the patient

Page 18: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:
Page 19: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Clinical staging for Schizophrenia??Clinical staging for Schizophrenia?? (McGorry et al; (McGorry et al; World Psychiatry World Psychiatry 2008;7:148-156)2008;7:148-156)

Stage 1: Ultra-high risk: Pre psychosis Stage 1: Ultra-high risk: Pre psychosis stage.stage.

Stage 2: Early detection and treatment of Stage 2: Early detection and treatment of first episode psychosis.first episode psychosis.

Page 20: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Clinical staging for Schizophrenia??Clinical staging for Schizophrenia?? (McGorry et al; (McGorry et al; World Psychiatry World Psychiatry 2008;7:148-156)2008;7:148-156)

Stage 3: The critical period of the first 5 Stage 3: The critical period of the first 5 years after diagnosis:years after diagnosis:

Page 21: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Clinical staging for Schizophrenia??Clinical staging for Schizophrenia?? (McGorry et al; (McGorry et al; World Psychiatry World Psychiatry 2008;7:148-156)2008;7:148-156)

period of maximum risk for disengagement, relapse period of maximum risk for disengagement, relapse and suicide, as well as coinciding with the major and suicide, as well as coinciding with the major developmental challenges of forming a stable identity, developmental challenges of forming a stable identity, peer network, vocational training and intimate peer network, vocational training and intimate relationships. relationships.

Treatment goals in this phase are the management of Treatment goals in this phase are the management of effective medication and the use of effective effective medication and the use of effective psychosocial interventions to minimize the psychosocial interventions to minimize the development of disability and maximize functioning.development of disability and maximize functioning.

Page 22: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Gap of 1-10 days in Gap of 1-10 days in medicationmedication

The medication status is also the strongest The medication status is also the strongest predictor of relapse; discontinuation of predictor of relapse; discontinuation of medication increases the relapse risk five medication increases the relapse risk five foldsfolds99 . Even a gap as small as 1-10 days . Even a gap as small as 1-10 days in medication over one year period has in medication over one year period has been found to be significantly associated been found to be significantly associated with increased risk of hospitalization with with increased risk of hospitalization with an odds ratio of 1.98 an odds ratio of 1.98

Page 23: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The prevalenceThe prevalence

The large populations in developing The large populations in developing countries have much high prevalence of countries have much high prevalence of chronic mental disorders. chronic mental disorders.

One state in India has amore people One state in India has amore people suffering from Schizophrenia than those suffering from Schizophrenia than those living in whole of Americasliving in whole of Americas22. .

Page 24: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

45% < 45.45% < 45.

The age structure of LAMI countriesThe age structure of LAMI countries In Pakistan, 45% of population is below In Pakistan, 45% of population is below

45 years of ag45 years of ag The prevalence of those with first The prevalence of those with first

episode psychosis will be much higher episode psychosis will be much higher than those in the industrialized countries.than those in the industrialized countries.

Page 25: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Where is the evidence Where is the evidence for LAMI?for LAMI?

The “natural course” of Schizophrenia in The “natural course” of Schizophrenia in developing countriesdeveloping countries

Page 26: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

““Natural’’ course of Natural’’ course of schizophreniaschizophrenia

““Our original expectancy was that the Our original expectancy was that the naturalnatural course course of schizophrenia would be of schizophrenia would be favourable in a rural area of China.favourable in a rural area of China. In In every instance, however, the results also every instance, however, the results also supported thesupported the conclusion that the natural conclusion that the natural course of schizophrenia, especiallycourse of schizophrenia, especially

clinical outcome, was poor - clinical outcome, was poor - eveneven in a in a Chinese rural area”. Chinese rural area”.

Page 27: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Present level of Present level of “ Natural” course “ Natural” course

““One disappointment is that the proportion of One disappointment is that the proportion of patients receivingpatients receiving no treatment at all has no treatment at all has increased (30.6% in this study), ratherincreased (30.6% in this study), rather than than decreased (20.3% in 1982)”decreased (20.3% in 1982)”

, M. S., Xiang, M. Z., Huang, M. S., , M. S., Xiang, M. Z., Huang, M. S., et alet al (2001) (2001) Natural course of schizophrenia: two-year Natural course of schizophrenia: two-year follow-up study in a rural Chinese community. follow-up study in a rural Chinese community. British Journal of PsychiatryBritish Journal of Psychiatry, , 178178, 154 -158., 154 -158.

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“ “ Natural” courseNatural” course

Unknown but must be close to 90% of Unknown but must be close to 90% of untreated and partially treated.untreated and partially treated.

Page 29: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:
Page 30: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The relationship between the duration of untreated The relationship between the duration of untreated psychosis and outcome in low-and-middle income psychosis and outcome in low-and-middle income countries: A systematic review and meta analysiscountries: A systematic review and meta analysisSaeed Farooq Matthew Large,Olav Nielssen , Waquas Saeed Farooq Matthew Large,Olav Nielssen , Waquas Waheed. Schizophrenia Research.(109);2009. 15-23Waheed. Schizophrenia Research.(109);2009. 15-23

Significant negative correlation between Significant negative correlation between DUP and improvement in symptoms after DUP and improvement in symptoms after treatment (r=−0.290, 95% CI=−0.483 to treatment (r=−0.290, 95% CI=−0.483 to −0.069, z=−2.559, p<0.011) . The value −0.069, z=−2.559, p<0.011) . The value remained unchanged using both random remained unchanged using both random effect model and fixed effect model.effect model and fixed effect model.

Page 31: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The relationship between the duration The relationship between the duration of untreated psychosis and outcome in of untreated psychosis and outcome in low-and-middle income countries: A low-and-middle income countries: A systematic review and meta analysissystematic review and meta analysis

Prolonged DUP was also associated with Prolonged DUP was also associated with increased levels of disability.increased levels of disability.

Longer DUP associated with a higherLonger DUP associated with a higher

mortality ?mortality ?

Page 32: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Cohen et al. Questioning an Axiom: Better Cohen et al. Questioning an Axiom: Better Prognosis for Schizophrenia in the Prognosis for Schizophrenia in the Developing World? Developing World? Schizophrenia Schizophrenia Bulletin ,2008. 34, 229–244.Bulletin ,2008. 34, 229–244.

Page 33: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Relationship between Gross Domestic ProductRelationship between Gross Domestic Productand Duration of Untreated Psychosis in low andand Duration of Untreated Psychosis in low andmiddle-income countriesmiddle-income countriesMatthew Large, Saeed Farooq, Olav Nielssen and Tim SladeMatthew Large, Saeed Farooq, Olav Nielssen and Tim Slade The British Journal of Psychiatry (2008) The British Journal of Psychiatry (2008)193, 272–278. doi: 10.1192/bjp.bp.107.041863193, 272–278. doi: 10.1192/bjp.bp.107.041863

The average mean DUP in studies from LAMI The average mean DUP in studies from LAMI countries was 125.0 weeks compared with countries was 125.0 weeks compared with 63.4 weeks in studies from high income 63.4 weeks in studies from high income countries (P=0.012). Within the studies from countries (P=0.012). Within the studies from LAMI countries, mean DUP fell by 6 weeks for LAMI countries, mean DUP fell by 6 weeks for every $1000 of GDP purchasing power parity.every $1000 of GDP purchasing power parity.

Page 34: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Relationship between gross domestic Relationship between gross domestic product and duration of untreated product and duration of untreated psychosis in low and middle-income psychosis in low and middle-income countriescountries

There appears to be an inverse There appears to be an inverse relationship between income and DUP in relationship between income and DUP in LAMI countries. The cost of treatment is LAMI countries. The cost of treatment is an impediment to care and subsidised an impediment to care and subsidised antipsychotic medication would improve antipsychotic medication would improve the access to treatment and the outcome the access to treatment and the outcome of psychotic illness in LAMI countries.of psychotic illness in LAMI countries.

Page 35: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

The Challenge for Mental The Challenge for Mental Health ProfessionalsHealth Professionals

Change the Culture of Care in Chronic Change the Culture of Care in Chronic mental illness,mental illness,

Strive for the “Unnatural “ course of Strive for the “Unnatural “ course of illness illness

Page 36: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

ConclusionConclusion

Natural Course of Schizophrenia in LAMI Natural Course of Schizophrenia in LAMI is not benignis not benign

DUP is related with poor outcome and DUP is related with poor outcome and incomeincome

Clinical staging in schizophrenia may be Clinical staging in schizophrenia may be possiblepossible

We must aim to change the ‘natural’ We must aim to change the ‘natural’ course.course.

Page 37: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Thank you – break now!!Thank you – break now!!

Page 38: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

DOTS IS COST EFFECTIVEDOTS IS COST EFFECTIVE

The World Bank considers DOTS to be The World Bank considers DOTS to be one of the most cost effective health one of the most cost effective health interventions. DOTS is more cost interventions. DOTS is more cost effective than self-administered effective than self-administered treatment.treatment.

Page 39: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

What DOTS can offer for What DOTS can offer for chronic conditions like chronic conditions like schizophreniaschizophrenia

Regular Follow upRegular Follow up Regular Regular freefree supply of drugs supply of drugs Continuity of careContinuity of care Education for the relativesEducation for the relatives Reduced Stigma?Reduced Stigma?

Page 40: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

RATIONALERATIONALE

Patients suffering from Patients suffering from Schizophrenia need Schizophrenia need supervision and it is supervision and it is possible.possible.

Page 41: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

RATIONALE: RATIONALE: We owe it to the We owe it to the familyfamily

Our family has largely ‘subsidized’ the Our family has largely ‘subsidized’ the treatment of schizophrenia for the society treatment of schizophrenia for the society and the state at large by providing the and the state at large by providing the social, psychological, residential and social, psychological, residential and occupational support which constitute the occupational support which constitute the major proportion of the cost of treatment major proportion of the cost of treatment

Page 42: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

OR PERHAPS!!OR PERHAPS!!

STOPS (Supervised Treatment in STOPS (Supervised Treatment in Out Patients for Schizophrenia, Out Patients for Schizophrenia, Short course Short course ) ? ) ?

Short course: At least Short course: At least two yearstwo years

Page 43: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

How STOPS work?How STOPS work?

Referral Referral EvaluationEvaluation Schizophrenic from district PeshawarSchizophrenic from district Peshawar consent for a relative to supervise his/her consent for a relative to supervise his/her

treatmenttreatment Key Care Supervisor (KCS) who agrees Key Care Supervisor (KCS) who agrees

to supervise the treatment of the patientto supervise the treatment of the patient

Page 44: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Essential components of Essential components of DOTSDOTS

A regular uninterrupted provision ofA regular uninterrupted provision of

FREE DRUGS TO THE ACTIVE CASESFREE DRUGS TO THE ACTIVE CASESStandardized treatment regimen of six to Standardized treatment regimen of six to eight months ofeight months of DRUG THERAPY UNDER DRUG THERAPY UNDER SUPERVISIONSUPERVISION

Page 45: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:
Page 46: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

How STOPS works?...... contHow STOPS works?...... cont

Provision of drugs free of costProvision of drugs free of cost for one month for one month Involving family in overall management planInvolving family in overall management plan

Family education regardingFamily education regarding Nature of disorder and its likely outcome. Nature of disorder and its likely outcome. Supervision of treatment Supervision of treatment

(monitoring the drug compliance by observing and (monitoring the drug compliance by observing and recording the correct medication)recording the correct medication)

Early relapse signsEarly relapse signs and its management by the and its management by the familyfamily

Page 47: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

How DOTSS work?.......contHow DOTSS work?.......cont The patients collect supply of the drugs every The patients collect supply of the drugs every

month and relatives have to satisfy the staff month and relatives have to satisfy the staff that patient is taking drugs regularly. that patient is taking drugs regularly.

If patient is unable to come and misses an If patient is unable to come and misses an appointment, we will contact him her at home appointment, we will contact him her at home and persuade to continue the treatment. and persuade to continue the treatment.

If patient has a relapse despite being on If patient has a relapse despite being on treatment, he will either be admitted in treatment, he will either be admitted in psychiatry unit or will be seen more frequently psychiatry unit or will be seen more frequently

Page 48: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Review After One Month Review After One Month Assess psychopathology Assess psychopathology Rate for improvement/ worsening G.A.F. Rate for improvement/ worsening G.A.F. Check for compliance ( check tablets/relatives report Check for compliance ( check tablets/relatives report

Stable

Continue the drug according to the phase of treatment

Not stable

Continue the drug according to the phase of treatment

RelapseNo improvementWorsening of symptoms Doubtful complianceReview by the consultant psychiatrist

Stable &discharge Admit

Continue out-patient assessment weekly till patient is stable

Page 49: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

1.1. Patient presents with psychotic features Assessment by Patient presents with psychotic features Assessment by consultant psychiatristconsultant psychiatrist

2.2. Diagnosis of schizophrenia or schizo effective disorder Diagnosis of schizophrenia or schizo effective disorder according to ICD-10 criteria (Appendix –A) according to ICD-10 criteria (Appendix –A)

Meets the criteria for inclusion in programme. (Appendix – B), Meets the criteria for inclusion in programme. (Appendix – B), included in STOPS. included in STOPS.

Assessment for severity of disease, compliance and G.A.F (see Assessment for severity of disease, compliance and G.A.F (see Appendix-C)Appendix-C)

Consent obtained for supervision (Appendix-DConsent obtained for supervision (Appendix-D) ) Key Care Giver identified Key Care Giver identified KCG trained in drug monitoring and supervision ( Appendix – E) KCG trained in drug monitoring and supervision ( Appendix – E)

Provide one month of supply of drugs.Provide one month of supply of drugs.

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The Pilot ProjectThe Pilot Project Started in Sept 2004 Started in Sept 2004 Patients enrolled=92Patients enrolled=92 Male 70Male 70 Female 22Female 22 No follow up after 1No follow up after 1stst assessment 13 assessment 13 Mean age 34.84 SD=10.58Mean age 34.84 SD=10.58

Page 51: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

GAF at baselineGAF at baseline= = 60.4%60.4% patients have patients have GFA less than 50 GFA less than 50

Mean GAFat baseline=41.46 sd=28.84Mean GAFat baseline=41.46 sd=28.84 GAF at six months follow up= GAF at six months follow up= 75.7%75.7%

have GAF more than 50 have GAF more than 50 Mean GAF after six months=61.43 Mean GAF after six months=61.43

sd=23.76sd=23.76

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Page 54: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

A SOLUTION?A SOLUTION?

An intervention based on principles of An intervention based on principles of DOTS?DOTS?

Page 55: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

WHAT IS DOTS?WHAT IS DOTS?

Tuberculosis can spread the disease to 10-15 Tuberculosis can spread the disease to 10-15 persons on average persons on average

Partially treated cases Partially treated cases

Multiple Drug Resistant Tuberculosis (MDRTB)Multiple Drug Resistant Tuberculosis (MDRTB) Failure to receive treatmentFailure to receive treatment

TB epidemic TB epidemic

Page 56: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

DOTS IS COST EFFECTIVEDOTS IS COST EFFECTIVE

The World Bank considers DOTS to be The World Bank considers DOTS to be one of the most cost effective health one of the most cost effective health interventions. DOTS is more cost interventions. DOTS is more cost effective than self-administered effective than self-administered treatment.treatment.

Page 57: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

RATIONALE: RATIONALE: We owe it to the We owe it to the familyfamily

The family in developing countries has The family in developing countries has largely ‘subsidized’ the treatment of largely ‘subsidized’ the treatment of schizophrenia for the society and the schizophrenia for the society and the state at large by providing the social, state at large by providing the social, psychological, residential and psychological, residential and occupational support which constitute the occupational support which constitute the major proportion of the cost of treatment major proportion of the cost of treatment

Page 58: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

Short course : At least Short course : At least two yearstwo years

The Critical period in care of The Critical period in care of schizophreniaschizophrenia

Compliance intervention work optimally for Compliance intervention work optimally for upto 18 months.upto 18 months.

No developing country can afford to No developing country can afford to provide indefinite free treatmentprovide indefinite free treatment

MeasureableMeasureable

Page 59: Treating Schizophrenia in Low And Middle Income (LAMI) Countries: Challenges and opportunities Treating Schizophrenia in Low And Middle Income (LAMI) Countries:

How STOPS works.......contHow STOPS works.......cont The patients collect supply of the drugs every The patients collect supply of the drugs every

month and relatives have to satisfy the staff month and relatives have to satisfy the staff that patient is taking drugs regularly. that patient is taking drugs regularly.

If patient is unable to come and misses an If patient is unable to come and misses an appointment, we will contact him her at home appointment, we will contact him her at home and persuade to continue the treatment. and persuade to continue the treatment.

If patient has a relapse despite being on If patient has a relapse despite being on treatment, he will either be admitted in treatment, he will either be admitted in psychiatry unit or will be seen more frequently psychiatry unit or will be seen more frequently

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Follow up visitsFollow up visits

Assess psychopathology Assess psychopathology

Rate for improvement/ worsening G.A.F.Rate for improvement/ worsening G.A.F.

Check for compliance ( check Check for compliance ( check

tablets/relatives report)tablets/relatives report)

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The primary outcome was to compare The primary outcome was to compare the effectiveness of STOPS in improving the effectiveness of STOPS in improving the adherence with a regimenthe adherence with a regimen of standard of standard doses of antipsychotic medication in doses of antipsychotic medication in patients suffering from Schizophrenia patients suffering from Schizophrenia and Schizoaffective Disorders compared and Schizoaffective Disorders compared to Treatment As Usual (TAU)to Treatment As Usual (TAU)

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50% of the patients with Schizophrenia 50% of the patients with Schizophrenia adhere to medication over a period of adhere to medication over a period of one year one year 5, 75, 7

We expected the rate of medication We expected the rate of medication adherence to be 75% in the intervention adherence to be 75% in the intervention group. group.

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The power calculation showed that with The power calculation showed that with 55 patients in each arm of the trial, and 55 patients in each arm of the trial, and assuming a drop out rate of nearly assuming a drop out rate of nearly 20%, there was a 90% chance of 20%, there was a 90% chance of detecting a 25% difference in treatment detecting a 25% difference in treatment adherence at the 0.01% level of adherence at the 0.01% level of significance, should a such difference significance, should a such difference exist. exist.

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The randomization was done using The randomization was done using computer generated numbers. computer generated numbers.

The random allocation of the patients for The random allocation of the patients for each group was enclosed in series of each group was enclosed in series of opaque envelopes which were sealed opaque envelopes which were sealed and numbered sequentially.and numbered sequentially.

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These allocations were placed away from These allocations were placed away from the site of assessment. After assessment the site of assessment. After assessment and satisfying the inclusion criteria, the and satisfying the inclusion criteria, the independent staff in the administration independent staff in the administration office was asked to open the sealed office was asked to open the sealed envelope and reveal the treatment arm envelope and reveal the treatment arm for each patient.for each patient.

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Fifty five patients recruited in each arm. Fifty five patients recruited in each arm. 95 (86.36%) patients completed the study; 49 in 95 (86.36%) patients completed the study; 49 in

STOPS and 46 TAU group. STOPS and 46 TAU group. The mean age of patients in STOPS group was 29 The mean age of patients in STOPS group was 29

(SD= 8.1) which did not differ significantly from the (SD= 8.1) which did not differ significantly from the TAU group (mean 30, SD= 8.5, P< .699). TAU group (mean 30, SD= 8.5, P< .699).

The baseline sociodemographic and clinical variables The baseline sociodemographic and clinical variables were not significantly different in two groups were not significantly different in two groups

Both groups had long duration of illness (67.36 Both groups had long duration of illness (67.36 months SD=59 in STOPS Vs 83.8 months in TAU; months SD=59 in STOPS Vs 83.8 months in TAU; SD=91 P< .485).SD=91 P< .485).

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Adherence with Adherence with medicationmedication

The rates of adherence with medication The rates of adherence with medication improved significantly in the intervention improved significantly in the intervention arm. At one year follow up, 37 (67.3%) arm. At one year follow up, 37 (67.3%) patients in STOPS group had complete patients in STOPS group had complete adherence with medication compared to adherence with medication compared to 25 (45.5%) in the TAU group 25 (45.5%) in the TAU group (P<.02).(P<.02).

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PANSS ScoresPANSS Scores

Analysis of Covariance (ANCOVA): Analysis of Covariance (ANCOVA): PANSS Total Scores, (time effect, Wilks’ PANSS Total Scores, (time effect, Wilks’

lambda=0.90, F(3,105)=3.54, P=0.017, and lambda=0.90, F(3,105)=3.54, P=0.017, and between the subject effect, F=9.0, df=1, between the subject effect, F=9.0, df=1, P=0.003P=0.003).).

PANSS Positive Symptoms (time effect, Wilks’ PANSS Positive Symptoms (time effect, Wilks’ lambda=0.91, F(3,102)=3.31, P=0.011, and lambda=0.91, F(3,102)=3.31, P=0.011, and between the subject effect, F=5.9, df=1, between the subject effect, F=5.9, df=1, P=0.003)P=0.003) . .

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PANSSPANSS

General PANSS scores, (time effect was General PANSS scores, (time effect was significant, Wilks’ lambda=0.92, significant, Wilks’ lambda=0.92, F(3,101)=2.57, F(3,101)=2.57, P=0.058P=0.058, and for between , and for between the subject effect, F=7.7, df=1, the subject effect, F=7.7, df=1, P=0.007)P=0.007)

PANSS Negative symptoms, Wilks’ PANSS Negative symptoms, Wilks’ lambda=0.94, F (3,102) =1.2, P=0.303, lambda=0.94, F (3,102) =1.2, P=0.303, nor between the subject effect, F=2.11, nor between the subject effect, F=2.11, df=1, df=1, P=0.149P=0.149

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GAF ScoresGAF Scores

Using ANCOVA, GAF scores were found Using ANCOVA, GAF scores were found to have significantly improved over time to have significantly improved over time in treatment group as compared with the in treatment group as compared with the treatment as usual group ( Wilks’ treatment as usual group ( Wilks’ lambda=0.90, F (3,106) =3.66, P=0.036, lambda=0.90, F (3,106) =3.66, P=0.036, and for between the subject effect, and for between the subject effect, F=7.3, df=1, F=7.3, df=1, P=0.008)P=0.008)..

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ConclusionConclusion

The two challenges:The two challenges: Compliance/adherence with treatmentCompliance/adherence with treatment

Supervised TreatmentSupervised Treatment Continuity of care and maintaining long term Continuity of care and maintaining long term

medicationmedication

Public Health Intervention on the model of DOTS Public Health Intervention on the model of DOTS with free drug provision under STOPS like with free drug provision under STOPS like programme for at least two years in First programme for at least two years in First Episode Psychosis.Episode Psychosis.