drugset / Trial / NCT00958568
A Study in Relapse Prevention of Treatment-Resistant Depression
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluoxetine | Small molecule | 25 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 50 mg | Oral |
| Subject | Olanzapine | Small molecule | 3 mg | Oral |
| Subject | Olanzapine | Small molecule | 6 mg | Oral |
| Subject | Olanzapine | Small molecule | 12 mg | Oral |
| Subject | Olanzapine | Small molecule | 18 mg | Oral |
Indications
No indication recorded.