A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- NIMH Symptom Severity Scale (for TTM or Skin Picking)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks
Intervention: Placebo (Drug)
Memantine
10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks
Intervention: Memantine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Hamilton Anxiety Rating Scale(8 weeks)
- Quality of Life Inventory (QOLI)(8 weeks)