A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
- Registration Number
- NCT00300846
- Brief Summary
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.
Exclusion Criteria
- Patients known to be allergic to aripiprazole
- Hospitalized patients
- Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 Placebo - A1 aripiprazole -
- Primary Outcome Measures
Name Time Method Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine. The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
- Secondary Outcome Measures
Name Time Method Effectiveness (IAQ, GAF) Patient Reported Outcomes Efficacy (PANSS, CGI) Safety
Trial Locations
- Locations (1)
Local Institution
🇬🇧London, United Kingdom