Efficacy of Agomelatine in Patients With Obsessive-Compul... | NCT01108393

Studies
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

NCT01108393

Sponsor

Institut de Recherches Internationales Servier

Status

Completed

Last Update Posted

Jul 25, 2024Actual

Enrollment

74Actual

Phase

Phase 2

Conditions

Obsessive Compulsive Disorder

Interventions

Agomelatine A
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-016713-20	EudraCT Number

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Apr 9, 2010

First Submission Date that Met QC Criteria

Apr 21, 2010

First Posted Date

Apr 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2024

Last Update Posted Date

Jul 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Agomelatine A	Experimental		Drug: Agomelatine A
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Agomelatine A	Drug	Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet	Agomelatine A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
MADRS total score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Zohar, Prof.	Department of Psychiatry Chaim Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry Chaim Sheba Medical Center		Tel Litwinsky			Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

URL

http://clinicaltrials.servier.com

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided