Efficacy of Aripiprazole adjunctive treatment on body weight, metabolic parameters, clinical efficacy, and adverse events in people with psychotic disorders on treatment with Clozapine â?? A randomized, double-blind, placebo-controlled trial

Phase 3

• Conditions: Health Condition 1: null- Schizophrenia; Schizoaffective disorder; Antipsychotic induced weight gain; Metabolic syndrome

• Registration Number: CTRI/2013/02/003397
• Lead Sponsor: Christian Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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 (100-900 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGI Efficacy index score (CGI efficacy index 1, 2 or 5, 6). <br/ ><br>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. <br/ ><br>Timepoint: 16 weeks <br/ ><br>