Compulsive BuyingPhase 2NCT00830375
Memantine Treatment of Compulsive Buying
A Phase 2 study testing Memantine in people with Compulsive Buying, run by University of Minnesota at 2 sites in United States.
Trial summary
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Compulsive Buying
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2008to 1 Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ambulatory Research Center
Minneapolis, Minnesota, 55454
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: 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.
Read the 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.
- Conditions
- Compulsive Buying
- Being tested
- Memantine
- Keywords
- Buying, Shopping, Impulse Control
- Medical subject headings
- Typhus, Endemic Flea-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
10-30mg, by mouth, daily
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | 10-30mg, memantine Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)
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
Measured: from study start to study end (8-weeks) and is Investigator rated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study start1 Dec 2008
- Primary completion1 Aug 2010
- Study completion1 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Compulsive BuyingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Grant, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830375
- Sponsor's protocol ID
- 0806M37821
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2009
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine Treatment of Compulsive Buying: An Open-Label Study
- ClinicalTrials.gov ID
- NCT00830375
- Acronym / sponsor ID
- 0806M37821
- Conditions
- Compulsive Buying
- Keywords
- Buying, Shopping, Impulse Control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Dec 2008 (actual)
- Primary completion
- 1 Aug 2010 (actual)
- Study completion
- 1 Aug 2010 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 4 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: Memantine10-30mg, memantine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: Namenda10-30mg, by mouth, daily | Drug | Memantine |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Compulsive Buying
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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.
Jon Grant, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine in people with Compulsive Buying, run by University of Minnesota at 2 sites 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 3 inclusion and 14 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS) (time frame: from study start to study end (8-weeks) and is Investigator rated). It is what the study was designed to measure, not a finding.
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 29 Jul 2019.