drugset / Trial / NCT00095134
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Phase 3
Completed
630 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.
Timeline
- Start
- 2004-10
- Primary completion
- —
- Completion
- 2005-11
Outcome
Met primary endpoint
paper Mean (+/-SE) HRSD-17 scores improved more in the risperidone augmentation group than in the placebo group. PMID 17975181 ↗
paper difference, -2.8 +/- 0.72 [95% CI, -4.2 to -1.4]; P <0.001 PMID 17975181 ↗
Publications
- Pandina G, Turkoz I, Bossie C. Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder. J Affect Disord. 2013 Oct;151(1):384-91. doi: 10.1016/j.jad.2013.01.053. Epub 2013 Jul 10.
- Mahmoud RA, Pandina GJ, Turkoz I, Kosik-Gonzalez C, Canuso CM, Kujawa MJ, Gharabawi-Garibaldi GM. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. doi: 10.7326/0003-4819-147-9-200711060-00003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 1 mg | — |
| Subject | Risperidone | Other / unclassified | 2 mg | — |