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NCT01108393 Clinical Trial

Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:
Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01108393
Other study ID # CL2-20098-072
Secondary ID 2009-016713-20
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2010
Est. completion date April 2013

Study information
Verified date January 2020
Source Servier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date April 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Agomelatine A
Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet
• Placebo
Placebo

Locations
Country Name City State
Israel Department of Psychiatry Chaim Sheba Medical Center Tel Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Y-BOCS total score Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16. 16 weeks
Secondary NIMH-OC score 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. 16 weeks
Secondary MADRS total score Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16. 16 weeks
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