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

Phase 3

Withdrawn

• Conditions: Obsessive-compulsive disorder; OCD; 10002861

• Registration Number: NL-OMON32677
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

-patients meet the DSM IV criteria for obsessive-compulsive disorder with Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score > 16 if obsessions and compulsions and Y-BOCS score > 10 if only obsessions OR 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 and proficient in Dutch

Exclusion Criteria

- Y-BOCS > 30 or CGI-S (severity of psychopathology) of 6 (severely ill) of 7 (among the most extremely ill patients)
- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in Yale Brown obsessive-compulsive scale (Y-BOCS) from baseline to<br /><br>week 12 and the number of responders are the primary efficacy parameters.<br /><br>Criteria for response will be a 35% or greater change from baseline on the<br /><br>Y-BOCS and a final CGI rating of *much improved or *very much improved*.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The onset of response to treatment, using the time to a sustained response as<br /><br>criterion, side effect profiles, Quality of life as measured with the Sheehan<br /><br>disability scale. </p><br>