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1 Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar :47:34 GMT) CTRI Number Last Modified On 05/06/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/02/ [Registered on: 14/02/2013] - Trial Registered Prospectively Yes Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial Efficacy of Aripiprazole adjunctive treatment on body weight, metabolic parameters, clinical efficacy, and adverse events in people with psychotic disorders on treatment with Clozapine A randomized, double-blind, placebo-controlled trial Randomized, double-blind, placebo-controlled trial to evaluate the effects of adjunctive treatment with Aripiprazole on body weight, metabolic parameters, clinical efficacy, and adverse events in people with psychotic disorders on treatment with Clozapine Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL NIL Details of Principal Investigator Dr Prince Rajamanickam PG Registrar Phone Department of Psychiatry Bagayam princer@cmcvellore.ac.in Details Contact Person (Scientific Query) Dr Prathap Tharyan Professor of Psychiatry Phone Department of Psychiatry Bagayam Prof BV Moses Centre for Research and Training in Evidence-Informed Healthcare Carman Block II floor, CMC Campus, Bagayam prathap@cmcvellore.ac.in Details Contact Person (Public Query) Dr Prince Rajamanickam PG Registrar Department of Psychiatry page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone princer@cmcvellore.ac.in Source of Monetary or Material Support > Fluid Research Fund > Prof BV Moses Centre for Research and Training in Evidence-Informed Healthcare, Christian Medical College Primary Sponsor Details Bagayam Type of Sponsor List of Countries of Principal Investigator Dr Prince Rajamanickam Private medical college of Site Site Phone/Fax/ Department of Psychaitry Mental Health Center Christian Medical College Bagayam princer@cmcvellore.ac.i n of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Review Board, Christian Medical College, Status Not Applicable Health Type Patients Approved 19/11/2012 No Date No Date Specified Condition Schizophrenia; Schizoaffective disorder; Antipsychotic induced weight gain; Metabolic syndrome Type Details Intervention Aripiprazole (added to Clozapine) 1. Aripiprazole tablet 10 mg once daily at night for 1 week; then 15 mg once daily for 15 weeks; flexible dosing from week 3 to increase to 20 mg/day for psychiatric symptoms or reduce to 10 mg/day to reduce side effects + Clozapine (previous stable dose [ mg] for the duration of the trial) Comparator Agent Placebo (added to Clozapine) Identical placebo tablets for aripiprazole (10 mg) once daily at night for one week then 15 page 2 / 5

3 Inclusion Criteria Exclusion Criteria Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria mg placebo for. Flexible dosing from week 3 to increase to 20 mg/day for psychiatric symptoms or reduce to 10 mg/day to reduce side effects Plus Clozapine (previous stable dose [ mg] for the duration of the trial) 1. Patients diagnosed with schizophrenia or schizoaffective disorder according to ICD-10 criteria 2. Age 18 years or above 3. Should be on stable doses of Clozapine ( mg) for at least 4 weeks 4. Experiencing troublesome weight gain and are overweight or obese (according to Asian criteria) BMI of 25 kg/m2 with comorbidities such as type 2 diabetes mellitus, hypertension, or dyslipidemia; or BMI of 27kg/m2 without any comorbid conditions; or Waist circumference > 90 cm for males and > 80 cm for women Or: i. Have residual positive or negative psychotic or psychiatric symptoms with a minimum score on the Brief Psychiatric Rating Scale (BPRS) > 31 (CGI Severity score of 3 or>) on clozapine for at least three months and in whom dose increases are thought unwise due to sedation or troublesome side-effects (hyper-salivation, drowsiness) and who have failed trials with other, or are intolerant to other antipsychotic drugs. 5. Provides informed consent to participate in the study with additional assent from a responsible relative Exclusion Criteria 1. Women who are pregnant or breastfeeding, or unwilling to use a suitable method of contraception 2. Any organic condition or medical problem that would expose the patient to undue risk (as decided by the treating physician) 3. High suicidal risk or florid psychosis that would pose a threat of harm to others 4. Psychotic symptoms of such severity that are likely to result in altered doses of Clozapine during the trial Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Sequentially numbered, sealed, opaque envelopes Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints CGI Efficacy index score (CGI efficacy index 1, 2 or 5, 6). in symptomatic participants, or who achieve weight criteria that are normal for Asian populations (BMI less than 23 kg/m2) if overweight at start of trial, or who achieve weight criteria below obesity cut-offs (BMI less than 25 kg/m2) if obese at start of trial. page 3 / 5

4 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Proportions achieving weight criteria that are normal for Asian populations (BMI less than 23 kg/m2) if overweight at start of trial, or who achieve weight criteria below obesity cut-offs (BMI 25 kg/m2) if obese at start of trial. Mean change from baseline in body weight Proportion with CGI improvement scores of 3 or more Mean change in BPRS scores over baseline Proportion with greater than 50% reduction in BPRS scores from baseline Mean change in fasting sugars, triglycerides, lipids from baseline Proportion with HbsAg less than 7 Proportion with fasting blood sugars less than 100 mg/dl Proportion with triglycerides less than 150 mg/dl Proportion with HDL greater than 40 mg/dl for men; and greater than 50 mg/dl for women Extrapyramidal symptoms measured by the Simpson and Angus scale Sedation measured by the Epworth sleepiness scale Hypersalivation measured by the Nocturnal Hypersalivation Scale Other adverse events considered troublesome by participants or by treating physicians Compliance with diet (as assessed from self-reports of patients and from relatives) Compliance with exercise (as assessed by self-reports and from relatives) Total Sample Size=60 Sample Size from =60 15/02/2013 No Date Specified Years=1 Months=0 Days=0 Not Applicable Open to Recruitment 16 weeeks Over Objectives: To evaluate the effects of adjuant Aripiprazole versus adjuant placebo on body weight, metabolic parameters and clinical efficay in people with psychotic disorders on treatment with Clozapine with troublesome wight gain (overweight oor obese according to Asian criteria) and /or residual psychotic symptoms Methods:randomized, parallel-group, participant, treatment provider, outcome assessor, data entry operator and statistician blinded superiority trial Intervention: Aripiprazole 10 mg for 1 week; 15 mg daily for 3 weeks and flexible dosing for further page 4 / 5

5 Powered by TCPDF ( 12 weeks (10 mg to 20 mg) added to previous stable dose of Clozapine (100 to 900 mg) N = 30 Control: Identical placebo doses as for intervention, added to previous stable dose of Clozapine (100 mg to 900 mg) N = 30 Co-interventions: Dietary advice plus an exercise prescription for all participants Outcomes: Primary outcome- change in CGI efficacy index. Secondary outcomes: changes in weight, lipids, sugars, clinical symptoms; and emergence of adverse events. Analyses: will be by intention to treat page 5 / 5