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Memantine in Body Focused Repetitive Behaviors

Primary Purpose

Trichotillomania (Hair-Pulling Disorder), Dermatillomania

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Memantine
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania (Hair-Pulling Disorder)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. men and women age ≥18 years;
  2. current DSM-5 trichotillomania or skin picking disorder; and
  3. Ability to understand and sign the consent form.

Exclusion Criteria:

  1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
  2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
  4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
  5. Illegal substance use based on urine toxicology screening
  6. Stable dose of medications for at least the past 3 months
  7. Previous treatment with memantine
  8. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Memantine

Arm Description

10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks

10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks

Outcomes

Primary Outcome Measures

NIMH Symptom Severity Scale (for TTM or Skin Picking)
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.

Secondary Outcome Measures

Clinical Global Impressions-Improvement Scale (CGI-I)
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.
Massachusetts General Hospital Hairpulling (Skin Picking) Scale
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.
Skin Picking Symptom Assessment Scale
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.
Sheehan Disability Scale
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.
Hamilton Depression Rating Scale
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.
Hamilton Anxiety Rating Scale
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.

Full Information

First Posted
March 8, 2021
Last Updated
July 31, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04792645
Brief Title
Memantine in Body Focused Repetitive Behaviors
Official Title
A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is 8 weeks long and involves subjects taking memantine or placebo. If they are randomly assigned to the memantine arm and are eligible to participate in the study, they will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania (Hair-Pulling Disorder), Dermatillomania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks
Arm Title
Memantine
Arm Type
Experimental
Arm Description
10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
no other name
Intervention Description
Pill that contains no medicine
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda
Intervention Description
Cognition-enhancing medication
Primary Outcome Measure Information:
Title
NIMH Symptom Severity Scale (for TTM or Skin Picking)
Description
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.
Time Frame
The primary efficacy end points will be the change in these measures from baseline to week 8.
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Improvement Scale (CGI-I)
Description
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.
Time Frame
8 weeks
Title
Massachusetts General Hospital Hairpulling (Skin Picking) Scale
Description
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.
Time Frame
8 weeks
Title
Skin Picking Symptom Assessment Scale
Description
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.
Time Frame
8 weeks
Title
Sheehan Disability Scale
Description
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.
Time Frame
8 weeks
Title
Hamilton Depression Rating Scale
Description
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.
Time Frame
8 weeks
Title
Hamilton Anxiety Rating Scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Grant, JD, MD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27581696
Citation
Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
Results Reference
background
PubMed Identifier
23128921
Citation
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.
Results Reference
background
PubMed Identifier
23303052
Citation
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.
Results Reference
background
PubMed Identifier
27007062
Citation
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.
Results Reference
background
PubMed Identifier
20531220
Citation
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.
Results Reference
background
PubMed Identifier
1784653
Citation
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.
Results Reference
background

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Memantine in Body Focused Repetitive Behaviors

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