To determine the efficacy and safety of memantine for patients with OCD.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in Yale Brown obsessive-compulsive scale (Y-BOCS) from baseline to
week 12 and the number of responders are the primary efficacy parameters.
Criteria for response will be a 35% or greater change from baseline on the
Y-BOCS and a final CGI rating of *much improved or *very much improved*.
Secondary outcome
The onset of response to treatment, using the time to a sustained response as
criterion, side effect profiles, Quality of life as measured with the Sheehan
disability scale.
Background summary
Obsessive-compulsive disorder (OCD) is a chronic and disabling disease that
puts a high economic burden on the patient and on society. Recent
epidemiological studies have put the lifetime prevalence of OCD at 3%.
Despite, the availability of antidepressants, a substantial proportion of
patients with OCD do not respond to, or are intolerant of, standard treatments.
Additional treatment strategies are therefore necessary.
Recent data (at genetic level, as well as using neuroimaging) shows that
excessive action of the excitatory neurotransmitter glutamate may play a role
in the pathophysiology of OCD. Memantine blocks the excitatory action of
glutamate at the N-methyl- D-aspartate (NMDA) receptor under pathological
conditions. Small case studies in OCD patients suggest that memantine may have
efficacy in the treatment of OCD. These preliminary findings warrant larger,
placebo-controlled studies in OCD.
Study objective
To determine the efficacy and safety of memantine for patients with OCD.
Study design
The trial will be a randomised, double blind, placebo-controlled, flexible dose
study with memantine administered at 10 to 20 mg daily.
Intervention
Either memantine administered at 10 to 20 mg daily or identical placebo.
Study burden and risks
Using a very basic study design, harm will be limited. Blood will be drawn
three times to asses adherence. The investigational product has a relatively
mild side-effect profile, consisting of mainly dizziness, headaches,
constipation, drowsiness and hypertension which are reported slightly more
often than in placebo conditions.
Meibergdreef 5
1105 AZ
NL
Meibergdreef 5
1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016751-22-NL |
| CCMO | NL30312.018.09 |