Combined fluvoxamine and extended-release methylphenidate improved treatment response compared to fluvoxamine alone in patients with treatment-refractory obsessive-compulsive disorder: A randomized double-blind, placebo-controlled study

Eur Neuropsychopharmacol. 2019 Mar;29(3):397-404. doi: 10.1016/j.euroneuro.2018.12.010. Epub 2018 Dec 27.

Abstract

More effective, tolerable interventions for treatment-refractory obsessive-compulsive disorder (OCD) are needed. Preliminary findings encourage optimism that methylphenidate augmentation may be of benefit in the treatment of OCD. To test modulator methylphenidate (MPH) of extended-release formulations (MPH-ER) a safe and effective add-on therapy for refractory OCD, a pilot randomized, placebo-controlled, double-blind trial was conducted at an outpatient, single-center academic setting. Participants included 44 adults with serotonin reuptake inhibitor (SRI) treatment-refractory OCD and receiving a stable fluvoxamine pharmacotherapy with Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores higher than 20. Data were analyzed in the intention-to-treat sample. All subjects were randomized into two parallel groups to receive fluvoxamine (250 mg daily) plus MPH-ER (36 mg daily) or fluvoxamine (250 mg daily) plus identical placebo tablets under double-blind conditions and followed for 8 weeks. Forty-four patients (29 [66%] men), with a mean (SD) age of 24.7 (6) years participated; with a mean (SD) duration of episode 5.7 (3) were randomized and forty-one finished the trial. In the intention-to-treat analysis, the improvement in the Y-BOCS total score and Y-BOCS obsession subscale score was more prominent in the fluvoxamine and MPH-ER group compared with those receiving placebo (P < .001). Additionally, cumulative response rates were higher in the MPH-ER vs placebo groups (59% vs 5%; P < .001). MPH-ER was well tolerated; No subjects dropped out due to side effects. In summary, combined treatment with MPH-ER demonstrated an enhanced clinical rate of response compared to placebo. Further trials should examine MPH-ER efficacy in a larger sample.

Keywords: Augmentation; Methylphenidate (MPH) of extended-release formulations (MPH-ER); Treatment-refractory obsessive-compulsive disorder.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Dopamine Uptake Inhibitors / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluvoxamine / therapeutic use*
  • Humans
  • Male
  • Methylphenidate / therapeutic use*
  • Obsessive-Compulsive Disorder / drug therapy*
  • Psychiatric Status Rating Scales
  • Retrospective Studies
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Dopamine Uptake Inhibitors
  • Serotonin Uptake Inhibitors
  • Methylphenidate
  • Fluvoxamine