Institutional members access full text with Ovid®

Share this article on:

Ondansetron or placebo in the augmentation of fluvoxamine response over 8 weeks in obsessive–compulsive disorder

Heidari, Mahnaza; Zarei, Maryamb; Hosseini, Seyed M.R.b; Taghvaei, Rhelehb; Maleki, Haleha; Tabrizi, Minac; Fallah, Jalilb; Akhondzadeh, Shahinb

International Clinical Psychopharmacology: November 2014 - Volume 29 - Issue 6 - p 344–350
doi: 10.1097/YIC.0000000000000043
Original Articles

The aim of this study was to investigate the efficacy and safety of ondansetron as an augmentative agent to fluvoxamine in the treatment of patients with obsessive–compulsive disorder (OCD). Forty-six men and women, aged 18–60 years, who fulfilled the diagnostic criteria of OCD on the basis of the DSM-IV-TR and had a Yale–Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21 were recruited into the study. The patients randomly received either ondansetron (8 mg/day) or placebo for 8 weeks. All patients received fluvoxamine (100 mg/day) for the first 4 weeks, followed by 200 mg/day for the rest of the trial. The patients were assessed using the Y-BOCS and the adverse event checklists at baseline, and the second, fourth, sixth, and eighth week. Forty-four patients completed the study. The Y-BOCS total score as well as the Y-BOCS obsession subscale score and compulsion subscale score showed significantly greater reduction in the ondansetron group than in the placebo group. There was no significant difference in adverse events between the two groups. In this 8-week double-blind randomized-controlled trial, ondansetron showed significant beneficial effect as an augmentative agent with fluvoxamine in patients with moderate to severe OCD and it was generally well tolerated.

aReproductive Biotechnology Research Center, Avicenna Research Institute (ARI), ACECR

bPsychiatric Research Center, Roozbeh Psychiatric Hospital

cMedical Genetics Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran

Clinical Trial registry name and registration number: Iranian registry of clinical trials. Available at:, IRCT201204271556N41.

Correspondence to Shahin Akhondzadeh, PhD, Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran Tel: +98 21 88281866; fax: +98 21 55419113, e-mail:

Received February 1, 2014

Accepted April 9, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins