- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00830375
Memantine Treatment of Compulsive Buying
July 10, 2019 updated by: University of Minnesota
Memantine Treatment of Compulsive Buying: An Open-Label Study
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
Study Overview
Detailed Description
The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying.
Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine.
The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying.
The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota
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Minneapolis, Minnesota, United States, 55454
- Ambulatory Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- men and women age 18-65
- current CB using the clinician-administered Structured Clinical Interview for Compulsive buying (SCI-CB)
- buying behavior within 2 weeks prior to enrollment
Exclusion Criteria:
- infrequent buying (i.e. less than one time per week) that does not meet proposed criteria for CB
- unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
- history of seizures
- myocardial infarction within 6 months
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- a need for medication other than memantine with possible psychotropic effects or unfavorable interactions;
- clinically significant suicidality;
- current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders, except for nicotine dependence
- lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
- current or recent (past 3 months) DSM-IV substance abuse or dependence;
- positive urine drug screen at screening
- initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
- previous treatment with memantine
- treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Memantine
10-30mg, memantine
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10-30mg, by mouth, daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)
Time Frame: from study start to study end (8-weeks) and is Investigator rated
|
The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).
Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms
|
from study start to study end (8-weeks) and is Investigator rated
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jon Grant, MD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2008
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
January 23, 2009
First Submitted That Met QC Criteria
January 26, 2009
First Posted (Estimate)
January 27, 2009
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0806M37821
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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