Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: 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 [100-900 mg] for the duration of the trial
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance with diet (as assessed from self-reports of patients and from relatives)Timepoint: 16 weeks;Compliance with exercise (as assessed by self-reports and from relatives)Timepoint: 16 weeks;Extrapyramidal symptoms measured by the Simpson and Angus scaleTimepoint: 16 weeks;Hypersalivation measured by the Nocturnal Hypersalivation ScaleTimepoint: 16 weeks;Mean change from baseline in body weightTimepoint: 16 weeks;Mean change in BPRS scores over baselineTimepoint: 16 weeks;Mean change in fasting sugars, triglycerides, lipids from baselineTimepoint: 16 weeks;Other adverse events considered troublesome by participants or by treating physiciansTimepoint: Over 16 weeks;Proportion with CGI improvement scores of 3 or moreTimepoint: 16 weeks;Proportion with fasting blood sugars less than 100 mg/dlTimepoint: 16 weeks;Proportion with greater than 50% reduction in BPRS scores from baselineTimepoint: 16 weeeks;Proportion with HbsAg less than 7Timepoint: 16 weeks;Proportion with HDL greater than 40 mg/dl for men; and greater than 50 mg/dl for womenTimepoint: 16 weeks;Proportion with triglycerides less than 150 mg/dlTimepoint: 16 weeks;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.Timepoint: 16 weeks;Sedation measured by the Epworth sleepiness scaleTimepoint: 16 weeks | — |
Countries
India
Contacts
Public ContactDr Prince Rajamanickam
Christian Medical College
Outcome results
None listed