Efficacy of agomelatine in OCD

• Research type

  Research Study

• Full title

  Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder. A randomised, double-blind, placebo-controlled, parallel groups, international study.

• IRAS ID

  35355

• Contact name

  Naomi Fineberg

• Sponsor organisation

  Clinical Operations Project Manager

• Eudract number

  2009-016713-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The first option for drug treatment of Obsessive-Compulsive Disorder (OCD) is a type of antidepressant called Selective Serotonin Reuptake Inhibitors (SSRI). However, SSRIs are not effective in all patients with OCD therefore new treatments options are required. This study will investigate the effectiveness of a new treatment in patients with OCD. In order to determine whether this treatment is effective we will compare it with a placebo, a preparation that looks like the real drug but is in fact inactive. The study will assess the effects of this new treatment compared to placebo over a 16-week period on: - severity of OCD symptoms, - severity of depressive and anxious symptoms (because OCD patients often suffer from such symptoms) - sleep (because sleep disturbance can be associated with OCD), - social functioning (in other words, how OCD and treatment affect work, social and family life), - pharmacokinetics (what happens to the drug in the body). During the study participants will attend 7 scheduled visits during a period of 18 weeks. At these visits the main information for the study will be obtained via patient interviews and questionnaires. Participants will be randomly assigned to treatment with the new treatment or placebo. So that the results of the study are unbiased, neither the participants nor their research doctors will know which treatment group they have been assigned to. The study is funded by an international pharmaceutical company. It will be conducted in the UK and 5 other countries. Around 80 participants will be involved in this study (40 patients on active treatment; 40 on placebo).

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/21

• Date of REC Opinion

  5 May 2010

• REC opinion

  Further Information Favourable Opinion