CTRI‐02‐003397.

Trial name or title	Randomised, 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.
Methods	Allocation: randomised. Blindness: double‐blind. Duration: 16 weeks. Country: India.
Participants	Diagnosis: schizophrenia and schizoaffective (ICD‐10). Target sample size: 60. History: Participants on a stable dose of clozapine (100 mg to 900 mg), with residual positive or negative psychotic or psychiatric symptoms with a minimum score on the Brief Psychiatric Rating Scale (BPRS) > 31, experiencing troublesome weight gain, and are overweight or obese. Age: 18 years or above.
Interventions	Combination therapy: clozapine + aripiprazole (10 mg to 20 mg/day). Monotherapy: clozapine + placebo..
Outcomes	Clinical response: not clinical improved, and CGI (Efficacy index score). Mental state: BPRS. Adverse events: weight gain, SAS, sedation, hypersalivation. Others: BMI, fasting sugars, triglycerides, lipids from baseline, compliance with diet, compliance with exercise.
Starting date	First enrolment on February 2013.
Contact information	Prince Rajamanickam (princer@cmcvellore.ac.in).
Notes	Clinical trial registry India ID: CTRI/2013/02/003397. Sponsor: Christian Medical College.