Memantine in Body Focused Repetitive Behaviors

NCT04792645 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB20-1992
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania (Hair-Pulling Disorder); Dermatillomania

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary efficacy end points will be the change in these measures from baseline to week 8.

Secondary Outcomes (7)

• Clinical Global Impressions-Improvement Scale (CGI-I)

  8 weeks

• Massachusetts General Hospital Hairpulling (Skin Picking) Scale

  8 weeks

• Skin Picking Symptom Assessment Scale

  8 weeks

• Sheehan Disability Scale

  8 weeks

• Hamilton Depression Rating Scale

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Memantine

EXPERIMENTAL

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

Drug: Memantine

Interventions

Placebo DRUG

Pill that contains no medicine

Also known as: no other name

Placebo

Memantine DRUG

Cognition-enhancing medication

Also known as: Namenda

Memantine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (6)

• Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.

  PMID: 27581696 BACKGROUND

• 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.

  PMID: 23128921 BACKGROUND

• 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.

  PMID: 23303052 BACKGROUND

• 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.

  PMID: 27007062 BACKGROUND

• 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.

  PMID: 20531220 BACKGROUND

• 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.

  PMID: 1784653 BACKGROUND

MeSH Terms

Conditions

Trichotillomania; Excoriation Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Jon Grant
• Organization: University of Chicago

jongrant@uchicago.edu

773-834-3778

Study Officials

• Jon Grant, JD, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: June 15, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: September 19, 2024
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)