Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/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.

Phase 2

Conditions: psychiatrische en obsessieve en compulsieve stoornissen
Obsessive Compulsive Disorder

Registration Number: NL-OMON34855

Lead Sponsor: Servier R&D Benelux

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Out patients, male or female, between 18 and 65 years inclusive with a primary diagnosis of Obsessive Compulsive Disorder (OCD) according to DSM-IV-TR. The diagnosis will be documented by the brief structured interview M.I.N.I.
- Patients previously treated for OCD with a first line pharmacological treatment, i.e, SRI with or without cognitive behavioural therapy .
- Y-BOCS total score * 20 (moderately to severely ill),
- Duration of OCD symptoms of at least one year,
- Requiring a treatment.

Exclusion Criteria

cfr p. 25-26
- Episodic OCD, Exclusive hoarders, Early onset OCD
- Refractory patients defined as having not responded to 2 or more adequate treatments (medium or high) dose of a SRI for at least 12 weeks.
- Patients in psychiatric care for more than 5 years for OCD
- Naïve Patients (never received pharmacological treatment for OCD)
- Motor or verbal tic disorder (including Tourette*s),
- Substance or alcohol dependence or abuse
- personality disorders
- Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study (e.g., neurologic, neoplasic, cardiovascular, pulmonary, digestive or metabolic disorders like unstabilized diabetes of type I or II, morbid obesity, untreated or uncontrolled arterial hypertension*),
- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluation,
- Hepatic impairment (i.e. cirrhosis or active liver disease),
- ASAT or ALAT values * 2 times the upper reference value
- Total bilirubin * 2 times the upper reference value or ALAT and total bilirubin >ULN
- Alkaline Phosphatase * 3 times the upper reference value,
- Women of childbearing potential without effective contraception (oral contraceptive pill, Intra-uterine contraceptive device or condom) as well as
- pregnant or breastfeeding women
- Concomitant psychotropic medications are forbidden during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Y-BOCS total score (expressed as the change from baseline to last post-baseline<br /><br>value on W0-W16 period) will be used to demonstrate the superiority of<br /><br>agomelatine compared to placebo on OC symptoms. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- National Institute of Mental Health-Obsessive-Compulsive Scale score (NIMH-OC)<br /><br>- CGI Severity of Illness and Global Improvement scores<br /><br>- Obsessive Compulsive Visual Aanalogue Scale (OC-VAS)<br /><br>- Montgomery and Asberg depression rating scale (MADRS) total score<br /><br>- Hamilton Rating Scale for Anxiety (HAM-A) total score<br /><br>- Getting off to sleep score, Quality of sleep score, Sleep awakening score and<br /><br>Integrity of behaviour score obtained from the Leeds Sleep Evaluation<br /><br>Questionnaire (LSEQ).<br /><br>- Work, Social life and Family life scores obtained from Sheehan disability<br /><br>scale<br /><br>- Adverse events<br /><br>- Sitting blood pressure (SBP (mmHg) and DBP (mmHg)) and heart rate (bpm).<br /><br>- Body weight (kg) and BMI (kg/m²).<br /><br>- Laboratory parameters.</p><br>