search
Back to results

Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Agomelatine A
Placebo
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Agomelatine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Agomelatine A

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 9, 2010
Last Updated
January 2, 2020
Sponsor
Institut de Recherches Internationales Servier
search

1. Study Identification

Unique Protocol Identification Number
NCT01108393
Brief Title
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, Agomelatine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agomelatine A
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Agomelatine A
Intervention Description
Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Y-BOCS total score
Description
Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
NIMH-OC score
Description
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.
Time Frame
16 weeks
Title
MADRS total score
Description
Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, Prof.
Organizational Affiliation
Department of Psychiatry Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
http://clinicaltrials.servier.com
Links:
URL
http://clinicaltrials.servier.com/wp-content/uploads/CL2-20098-072_synopsis_report.pdf
Description
Results summary

Learn more about this trial

Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

We'll reach out to this number within 24 hrs