Trials / Completed
CompletedNCT00300846
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (planned)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aripiprazole | Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional). |
| DRUG | Placebo | Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional) |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2006-03-10
- Last updated
- 2013-11-08
Locations
57 sites across 12 countries: Austria, Czechia, Finland, France, Germany, Hungary, Poland, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00300846. Inclusion in this directory is not an endorsement.