title: Granisetron adjunct to fluvoxamine for moderate to severe obsessive-compulsive disorder: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Several small studies have shown beneficial effects of ondansetron, a serotonin 5-HT(3) receptor antagonist, in the treatment of obsessive-compulsive disorder (OCD). The efficacy of other 5-HT(3) receptor antagonists in patients with OCD is still unclear. Granisetron does not alter cytochrome P450 activity and might have a lower risk of drug interactions, a longer duration of action and a better tolerability profile than other 5-HT(3) receptor antagonists.
  
  
  OBJECTIVE
  The objective of this study was to assess the efficacy and tolerability of granisetron augmentation of fluvoxamine in patients with OCD.
  
  
  METHODS
  This was a two-centre, randomized, double-blind, placebo-controlled, parallel-group study conducted from November 2011 to March 2012.
  
  
  METHODS
  The study setting was outpatient clinics of two large referral centres.
  
  
  METHODS
  Study participants were men and women, aged 18-60 years, who met the diagnostic criteria of OCD based on the DSM-IV-TR and who had a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21.
  
  
  METHODS
  Participants were randomly assigned to granisetron (Kytril(®); SmithKline Beecham, Philadelphia, PA, USA) 1 mg every 12 hours or placebo every 12 hours in addition to fluvoxamine for 8 weeks.
  
  
  METHODS
  Patients were assessed using the Y-BOCS at baseline, second, fourth, sixth and eighth weeks. The primary outcome measure was the difference in the score change of Y-BOCS total score from baseline to week 8 between the two groups. We also compared changes in the obsession and compulsion subscales of the Y-BOCS, and frequencies of partial response (≥25% reduction in Y-BOCS score), complete response (≥35% reduction in Y-BOCS score) and remission (Y-BOCS score ≤16) between the two groups.
  
  
  RESULTS
  Of the 42 included patients, 39 (20 in the placebo group, 19 in the granisetron group) completed the study. Significant time X treatment interaction was observed for total Y-BOCS (F [2.097, 79.678] = 4.941, p = 0.009), obsession (F [2.337, 88.799] = 4.938, p = 0.006) and compulsion (F [2.050, 77.899] = 4.674, p = 0.012) subscales. By week 8, complete response and remission were achieved by 20 (100%) and 18 (90%) patients in the granisetron group and by 7 (35%) patients in the placebo group (p-value of Fisher's exact test <0.001, risk ratio (RR) [95% CI] = 3.857 [2.039, 7.297]). There was no significant difference in the tolerability between the two regimens.
  
  
  CONCLUSIONS
  Granisetron is an efficacious adjunct for the short-term treatment of patients with moderate to severe OCD and is well tolerated.
  
  
  BACKGROUND
  IRCT201202041556N32.
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Neda
authors.initials: N
authors.lastname: Askari
authors.forename: Mahdieh
authors.initials: M
authors.lastname: Moin
authors.forename: Mohammad
authors.initials: M
authors.lastname: Sanati
authors.forename: Masih
authors.initials: M
authors.lastname: Tajdini
authors.forename: Seyed-Mohammad-Reza
authors.initials: SM
authors.lastname: Hosseini
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.forename: Babak
authors.initials: B
authors.lastname: Najand
authors.forename: Samrand
authors.initials: S
authors.lastname: Salimi
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.forename: Reza
authors.initials: R
authors.lastname: Hajiaghaee
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects / Q000627:therapeutic use*; D017829:Granisetron / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016666:Fluvoxamine; D017829:Granisetron; D058831:Serotonin 5-HT3 Receptor Antagonists