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Clinical Trials/CTRI/2013/02/003397
CTRI/2013/02/003397RecruitingPhase 3

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

Christian Medical College0 sites60 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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
  • •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

Investigators

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