- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792645
Memantine in Body Focused Repetitive Behaviors
A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors
Study Overview
Status
Intervention / Treatment
Detailed Description
The goal of the proposed study is to evaluate the efficacy and safety of memantine in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD).
The hypothesis to be tested is that memantine will be more effective and well tolerated in adults with trichotillomania or skin picking disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where there are not any current treatments options.
This will be one of few studies assessing the use of pharmacotherapy for the treatment of TTM and SPD in adults. Assessing the efficacy and safety of memantine will help inform clinicians about additional treatment options for adults suffering from this disorder.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- men and women age ≥18 years;
- current DSM-5 trichotillomania or skin picking disorder; and
- Ability to understand and sign the consent form.
Exclusion Criteria:
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
- Illegal substance use based on urine toxicology screening
- Stable dose of medications for at least the past 3 months
- Previous treatment with memantine
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks
|
Pill that contains no medicine
Other Names:
|
Experimental: Memantine
10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks
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Cognition-enhancing medication
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIMH Symptom Severity Scale (for TTM or Skin Picking)
Time Frame: The primary efficacy end points will be the change in these measures from baseline to week 8.
|
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score.
The entire study lasts 10 weeks.
Every two weeks subjects will take the NIMH Symptom Severity Scale.
The change in scores from baseline to after 8 weeks will be assessed.
The scale itself assesses severity of trichotillomania or skin picking symptom, with higher scores indicating greater trichotillomania or skin picking severity.
Score range: 0-20.
|
The primary efficacy end points will be the change in these measures from baseline to week 8.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impressions-Improvement Scale (CGI-I)
Time Frame: 8 weeks
|
The entire study for the subject will last 8 weeks.
Every two weeks the subject will complete the CGI-I.
The scale is a clinician-rated measure of overall disorder severity.
Scores range from 1 (not at all improved) to 7 (very much improved).
In each group, the number of people in each group who had a CGI-I score of 6 or 7 at Week 8 (indicating much or very much improved) will be presented.
|
8 weeks
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Massachusetts General Hospital Hairpulling (Skin Picking) Scale
Time Frame: 8 weeks
|
Brief, self-report scale for assessing repetitive hairpulling (or skin picking).
Because of a lack of an identical scale for skin-picking behavior, this scale was modified for skin picking for individuals with SPD to keep the outcome measure consistent across disorders.
Seven individual items, rated for severity from 0 to 4, assess urges to pull (pick), actual pulling (picking), perceived control, and associated distress (range 0-28).
The change in scores from baseline to after 8 weeks is reported.
Negative values indicate a decrease in score from baseline to 8 weeks, while positive values indicate an increase in score from baseline to 8 weeks.
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8 weeks
|
Skin Picking Symptom Assessment Scale
Time Frame: 8 weeks
|
The entire study lasts 8 weeks.
Every two weeks subjects will take the Skin Picking Symptom Assessment Scale (SP-SAS).
The scale itself assesses severity of skin-picking symptoms.
The SP-SAS score ranges from 0 to 48, with 0 being no symptoms and 48 being the most severe.
The average change in score from baseline to Week 8 will be reported for both groups.
A positive value indicates an increase in score from baseline to week 8, whereas a negative value indicates a decrease in score from baseline to week 8.
|
8 weeks
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Sheehan Disability Scale
Time Frame: 8 weeks
|
Subjects will complete the Sheehan Disability Scale (SDS) at all visits.
The SDS is a self-report measure of functional impairment.
Scores range from 0-30, with higher scores indicating greater functional impairment.
The average change in score from baseline to Week 8 will be reported.
Negative values indicate a decrease in score from baseline to Week 8, while positive values indicate an increase in score.
|
8 weeks
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Hamilton Depression Rating Scale
Time Frame: 8 weeks
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A clinician-administered assessment of depression that will be assessed at all study visits.
Score range 0-58.
Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
The change in score from baseline to Week 8 is reported.
Positive values indicate an increase in score from baseline to Week 8, whereas negative values indicate a decrease in score from baseline to Week 8.
|
8 weeks
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Hamilton Anxiety Rating Scale
Time Frame: 8 weeks
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A clinician-administered assessment of anxiety that will be assessed at all study visits.
Score range: 0-56.
Higher scores indicate more anxiety symptoms, with 0 being no symptoms of anxiety.
Changes in scores from baseline to week 8 visit will be assessed.
Positive values indicate an increase in score from baseline to week 8, whereas negative values indicate a decrease in score from baseline to week 8.
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8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon Grant, JD, MD, MPH, University of Chicago
Publications and helpful links
General Publications
- Cloninger CR, Przybeck TR, Svrakic DM. The Tridimensional Personality Questionnaire: U.S. normative data. Psychol Rep. 1991 Dec;69(3 Pt 1):1047-57. doi: 10.2466/pr0.1991.69.3.1047.
- Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
- Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508.
- Grant JE, Odlaug BL, Hampshire A, Schreiber LR, Chamberlain SR. White matter abnormalities in skin picking disorder: a diffusion tensor imaging study. Neuropsychopharmacology. 2013 Apr;38(5):763-9. doi: 10.1038/npp.2012.241. Epub 2012 Nov 29.
- Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.
- Grant JE, Odlaug BL, Chamberlain SR, Kim SW. A double-blind, placebo-controlled trial of lamotrigine for pathological skin picking: treatment efficacy and neurocognitive predictors of response. J Clin Psychopharmacol. 2010 Aug;30(4):396-403. doi: 10.1097/JCP.0b013e3181e617a1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Disruptive, Impulse Control, and Conduct Disorders
- Trichotillomania
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- IRB20-1992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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