Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Servier

Status and phase: Completed; Phase 2

Conditions: Obsessive Compulsive Disorder

Treatments: Drug: Agomelatine A; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01108393

CL2-20098-072

2009-016713-20 (EudraCT Number)

Details and patient eligibility

About

The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Agomelatine A

Experimental group

Treatment:

Drug: Agomelatine A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo