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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01108393
Enrollment
74
Registered
2010-04-22
Start date
2010-05-31
Completion date
2013-04-30
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder, Agomelatine

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.

Interventions

DRUGAgomelatine A

Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet

DRUGPlacebo

Placebo

Sponsors

Institut de Recherches Internationales Servier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Y-BOCS total score16 weeksYale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.

Secondary

MeasureTime frameDescription
NIMH-OC score16 weeksNational 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 score16 weeksMontgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026