Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
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
2 other identifiers
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 25, 2024
January 1, 2020
2.3 years
April 9, 2010
July 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
NIMH-OC score
16 weeks
MADRS total score
16 weeks
Study Arms (2)
Agomelatine A
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Bipolar disorder, Schizophrenic or Psychotic Disorder
- Severe or uncontrolled organic diseases
- Neurological disorder
- Women of childbearing potential who are not using effective contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry Chaim Sheba Medical Center
Tel Litwinsky, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Zohar, Prof.
Department of Psychiatry Chaim Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2010
First Posted
April 22, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2012
Study Completion
April 1, 2013
Last Updated
July 25, 2024
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies in patients: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.