A double blind, placebo controlled study of memantine in patients with obsessive-compulsive disorder. - Memantine monotherapy in OCD

Conditions: Obsessive-compulsive disorder (OCD)
MedDRA version: 12.0Level: LLTClassification code 10030029Term: OCD

Registration Number: EUCTR2009-016751-22-NL

Lead Sponsor: AMC, divisie Psychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- All patients meet the DSM IV criteria for obsessive-compulsive disorder
- Y-BOCS score > 16 if obsessions and compulsions
- Y-BOCS score > 10 if only obsessions
- Y-BOCS score > 10 if only compulsions
- Male and female, aged between 18-70 years
- Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception.
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presence of any of the following DSM IV conditions; major depression (with a HDRS>15, [17 item]), bipolar disorder, schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months, epilepsy, or any structural CNS disorder or stroke within the last year.
- Evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition abnormalities
- Patients at risk for suicide
- Cognitive and behavioural treatment 3 months prior to the screening visit
- Use of antipsychotics during 6 months before the screening visit
- Use of any other psychotropic drug during 3 months before the screening visit
- Multiple serious drug allergies or known allergy for the trial compound
- Any known contra-indication against memantine

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy and safety of memantine for patients with OCD who are medication-naive or free, or who have had a previous SRI treatment.;Secondary Objective: - the onset of response to treatment, using the time to a sustained response as criterion<br>- to evluatue side effect profiles<br>- to asses quality of life as measured with the Sheehan disability scale;Primary end point(s): - The change in Yale Brown obsessive-compulsive scale (Y-BOCS) from baseline to week 12 <br>- the number of responders defined as having a CGI–score of 1 or 2 (much improved or very much improved”), and a reduction of 35% on the Y-BOCS.

Secondary Outcome Measures