Clinical trial NCT04792645: Memantine in Body Focused Repetitive Behaviors
Official title: A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichotillomania (Hair-Pulling Disorder)
Dermatillomania
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: NIMH Symptom Severity Scale (for TTM or Skin Picking)
timeFrame: The primary efficacy end points will be the change in these measures from baseline to week 8.
Secondary outcomes:
measure: Clinical Global Impressions-Improvement Scale (CGI-I)
timeFrame: 8 weeks
measure: Massachusetts General Hospital Hairpulling (Skin Picking) Scale
timeFrame: 8 weeks
measure: Skin Picking Symptom Assessment Scale
timeFrame: 8 weeks
measure: Sheehan Disability Scale
timeFrame: 8 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 8 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 8 weeks
measure: Quality of Life Inventory (QOLI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon Grant, JD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
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.
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.
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.
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.
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.