Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
Phase 2
Completed
- Conditions
- Obsessive Compulsive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT01108393
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
- Y-BOCS total score ≥ 20,
- duration of OCD symptoms of at least one year.
Exclusion Criteria
- Bipolar disorder, Schizophrenic or Psychotic Disorder
- Severe or uncontrolled organic diseases
- Neurological disorder
- Women of childbearing potential who are not using effective contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Agomelatine A Agomelatine A - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Y-BOCS total score 16 weeks Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.
- Secondary Outcome Measures
Name Time Method NIMH-OC score 16 weeks National Institute for Mental Health- Obsessive Compulsive scale (NIMH-OC) Total Score. This scale measures the severity of obsessive and compulsive symptoms from baseline to week 16.
MADRS total score 16 weeks Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.
Trial Locations
- Locations (1)
Department of Psychiatry Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel