Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
Summary
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
Timeline
- Start
- 2007-05
- Primary completion
- 2010-03
- Completion
- 2010-04
Outcome
Missed primary endpoint
paper The Y-BOCS scores (mean [SD]) were significantly better in the placebo + fluoxetine and clomipramine + fluoxetine groups than in the quetiapine + fluoxetine group PMID 22020357 ↗
paper (reduction from baseline: -6.7 [confidence interval {CI}, -9.6 to -3.8; and -6.5 [CI, -9.0 to -3.9], respectively, vs -0.1 [CI, -2.9 to 2.7], P < 0.001; number needed to treat = 2.4). PMID 22020357 ↗
Publications
- Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8. doi: 10.1097/JCP.0b013e3182367aee.
- Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clomipramine | Small molecule | 75 mg | — |
| Comparator | Fluoxetine | Small molecule | 40 mg | — |
| Comparator | Fluoxetine | Small molecule | 80 mg | — |
| Subject | Quetiapine | Small molecule | 200 mg | — |