Obsessive-compulsive disorder (OCD) MedDRA version: 12.0 Level: LLT Classification code 10030029 Term: OCD
Conditions
Interventions
Trade Name: Ebixa
Product Name: memantine
Pharmaceutical Form: Tablet
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
CAS Number: 41100-52-1
Current Sponsor code: Ebixa
Other descriptive name: memantine
Sponsors
AMC, divisie Psychiatrie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - to evluatue side effect profiles - 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 - 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. | — |
Countries
Netherlands
Outcome results
None listed