Active — Not RecruitingPhase 2/3

Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

United States26 participantsStarted 2023-08-02

Plain-language summary

The goal of the proposed study is to compare the efficacy of behavioral treatment (BT) to memantine, a psychopharmacological agent, for BFRBs. 28 subjects with trichotillomania (TTM) or skin picking disorder (SPD) will receive 8 weeks of memantine treatment, followed by 8 weeks of comprehensive behavioral therapy (ComB) treatment. The hypothesis to be tested is that behavioral therapy will be associated with superior clinical outcomes as compared to memantine. A second hypothesis is that both memantine and behavioral therapy will demonstrate improvement from baseline to the respective posttreatment assessment.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women ages 18+ * Current DSM-5 diagnosis of trichotillomania (TTM) or skin picking disorder (SPD) * Ability to understand and sign the consent form * Stable dose of medications for at least the past 3 months 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) * 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 * Previous treatment with memantine * Previous trial of ComB or similar BT protocol (e,g., habit reversal training) * Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

What they're measuring

National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS)

Timeframe: The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.

Trial details

NCT IDNCT05796752

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06