Obsessive-Compulsive DisorderNCT00869505
Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder
An observational study of Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprised 44 subjects who received standard treatment at the MGH/ McLean Hospital OCD Institute Intensive Residential Treatment (IRT) program, admitted between May 1999 and December 2007.
Who may be able to join
- Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine.
- Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning.
Who cannot join
- Subjects offered memantine augmentation who did not provide voluntary consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
OCD Institute, McLean Hospital
Belmont, Massachusetts, 02478
About this study
Official title: A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute
Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- To evaluate the effectiveness of memantine as an augmenting agent for standard intensive residential treatment of severe obsessive-compulsive disorder (OCD)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Intensive Residential Treatment with memantine augmentation | |
| Control Group | Intensive Residential Treatment without memantine augmentation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OCD Institute, Mclean Hospital
- Investigators
- S. Evelyn Stewart, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869505
- Sponsor's protocol ID
- 2008-P-000461
- Status last verified
- Mar 2009
- First submitted
- 25 Mar 2009
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute
- ClinicalTrials.gov ID
- NCT00869505
- Acronym / sponsor ID
- 2008-P-000461
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- To evaluate the effectiveness of memantine as an augmenting agent for standard intensive residential treatment of severe obsessive-compulsive disorder (OCD)
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- OCD Institute, Mclean Hospital
- Study start
- Mar 2008
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Intensive Residential Treatment with memantine augmentation |
| Control Group | – | –Intensive Residential Treatment without memantine augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised 44 subjects who received standard treatment at the MGH/ McLean Hospital OCD Institute Intensive Residential Treatment (IRT) program, admitted between May 1999 and December 2007.
Key inclusion criteria (2 listed)
- Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine.
- Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning.
Key exclusion criteria (1 listed)
- Subjects offered memantine augmentation who did not provide voluntary consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Evelyn Stewart, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2009.