drugset / Trial / NCT00382291
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Phase 4
Completed
56 enrolled
University of Florida
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindDiagnostic
Summary
This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.
Timeline
- Start
- 2009-02
- Primary completion
- 2011-02
- Completion
- 2011-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Regular Titration vs Slow Titration; p = .2106; Kruskal-Wallis NCT00382291 ↗
registry analysis (superiority or other test); Placebo vs Regular Titration vs Slow Titration; p = .8831; ANCOVA NCT00382291 ↗
Publications
- Results Bussing R, Murphy TK, Storch EA, McNamara JP, Reid AM, Garvan CW, Goodman WK. Psychometric properties of the Treatment-Emergent Activation and Suicidality Assessment Profile (TEASAP) in youth with OCD. Psychiatry Res. 2013 Feb 28;205(3):253-61. doi: 10.1016/j.psychres.2012.09.019. Epub 2012 Sep 29.
- Reid AM, McNamara JP, Murphy TK, Guzick AG, Storch EA, Goodman WK, Geffken GR, Bussing R. Side-effects of SSRIs disrupt multimodal treatment for pediatric OCD in a randomized-controlled trial. J Psychiatr Res. 2015 Dec;71:140-7. doi: 10.1016/j.jpsychires.2015.10.006. Epub 2015 Oct 14.
- Bussing R, Reid AM, McNamara JP, Meyer JM, Guzick AG, Mason DM, Storch EA, Murphy TK. A pilot study of actigraphy as an objective measure of SSRI activation symptoms: results from a randomized placebo controlled psychopharmacological treatment study. Psychiatry Res. 2015 Feb 28;225(3):440-5. doi: 10.1016/j.psychres.2014.11.070. Epub 2014 Dec 10.
- Storch EA, Bussing R, Small BJ, Geffken GR, McNamara JP, Rahman O, Lewin AB, Garvan CS, Goodman WK, Murphy TK. Randomized, placebo-controlled trial of cognitive-behavioral therapy alone or combined with sertraline in the treatment of pediatric obsessive-compulsive disorder. Behav Res Ther. 2013 Dec;51(12):823-9. doi: 10.1016/j.brat.2013.09.007. Epub 2013 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 200 mg | — |