drugset / Trial / NCT00216281
Efficacy and Safety Study of Clozapine Augmented by Atomoxetine Versus Clozapine Augmented by Placebo in Patients With Chronic Resistant Schizophrenia
Phase 3
Terminated
126 enrolled
Indiana University
Hoffmann-La Roche · collabShekhar, Anantha M.D., Ph.D. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total sample size of 126 subjects diagnosed with schizophrenia and being treated with the antipsychotic clozapine will undergo genotyping. These subjects will have an initial assessment at four weeks and regular follow-up assessments for a total period of 52 weeks. These subjects will be randomized to continued treatment with CLZ and augmentation with ATX or Placebo.
Timeline
- Start
- 2005-09
- Primary completion
- 2006-10
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atomoxetine | Other / unclassified | 40 mg | — |
| Comparator | Clozapine | Other / unclassified | — | — |