KleptomaniaPhase 2NCT00880685

Memantine in the Treatment of Kleptomania

A Phase 2 study testing Memantine in people with Kleptomania, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Kleptomania
What is being tested?: Memantine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Jun 2012
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 KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
stealing behavior within 2 weeks prior to enrollment.

Who cannot join

infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (KM)
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

Show all 13Show fewer

clinically significant suicidality
current Axis I disorder determined by the Structured Clinical Interview for the DSM (SCID) and SCID-compatible modules for impulse control disorders (Grant et al., 2005), 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; and 14) 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

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55454

Other trials in United States

About this study

Official title: Memantine Treatment of Kleptomania: An Open-Label Study

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

Read the detailed description

The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Conditions: Kleptomania
Being tested: Memantine
Keywords: Compulsive Stealing, Compulsive Shoplifting
Medical subject headings: Disruptive, Impulse Control, and Conduct Disorders

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, daily for 8 weeks

Study groups in NCT00880685
Study group	Role	What they receive
Memantine	Experimental	Memantine 10-30mg 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 Kleptomania (KM-YBOCS)
Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Measured: Week 8 (last visit)

Secondary outcomes (2)

Kleptomania Symptom Assessment Scale (K-SAS)
Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Measured: Week 8 (last visit)
Clinical Global Impression Severity Scales (CGI)
The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Measured: Week 8 (last visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jun 2012

First posted14 Apr 2009 (estimated)
Study startMar 2009
Primary completionMay 2012
Study completionJun 2012

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 KleptomaniaStudies of the same condition, open and under way.
More trials run by University of ChicagoThe 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00880685
Sponsor's protocol ID: 0901M56882
Status last verified: Apr 2021
First submitted: 18 Mar 2009
Last updated: 24 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Memantine Treatment of Kleptomania: An Open-Label Study
ClinicalTrials.gov ID: NCT00880685
Acronym / sponsor ID: 0901M56882
Conditions: Kleptomania
Keywords: Compulsive Stealing, Compulsive Shoplifting
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Mar 2009
Primary completion: May 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 14 Apr 2009 (estimated)
Results: Posted 5 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

Detailed description

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: MemantineMemantine 10-30mg

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 KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
stealing behavior within 2 weeks prior to enrollment.

Key exclusion criteria (13 listed)

infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (KM)
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, daily for 8 weeks	Drug	Memantine

Primary outcome

Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
Time frame: Week 8 (last visit)
Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.

2 secondary outcomes

Kleptomania Symptom Assessment Scale (K-SAS)
Time frame: Week 8 (last visit)
Clinical Global Impression Severity Scales (CGI)
Time frame: Week 8 (last visit)

Results and safety

Results posted to the registry on 5 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Memantine 10mg-30mg	12	10

Primary outcome: Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)

Time frame: Week 8 (last visit). Mean (Standard Deviation). Unit: units on a scale

Measure	Memantine 10mg-30mg n = 12
Value	5.4 (4.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the beginning of the study until study completion (3 years). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Memantine 10mg	0 of 12 (0%)	3 of 12 (25%)	Not reported
Memantine 20mg	0 of 10 (0%)	4 of 10 (40%)	Not reported
Memantine 30mg	0 of 9 (0%)	2 of 9 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 E Grant, MD, JD principal investigator

University of Minnesota

1 site 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 Kleptomania, run by University of Chicago 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 3 inclusion and 13 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 24 May 2021. 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.

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 5 Mar 2014). 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 Kleptomania (KM-YBOCS) (time frame: Week 8 (last visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00880685.

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 24 May 2021.