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Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion moved earlier from Jun 2026 to Apr 16, 2026
    • Study completion pushed from Jun 2026 to Jun 2027
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Secondary endpoints: 8 to 7v12
  4. Primary and study completion dates: Dec 1, 2025 to Jun 2026v11
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 28 to confirmed 26
    • Primary and study completion dates: Mar 1, 2026 to Dec 1, 2025
    • Site details revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Dec 1, 2025 to Mar 1, 2026v9
  2. 2 versions Re-verified since Jan 6, 2025, no change to tracked fieldsv7-v8
  3. Primary and study completion dates: Dec 1, 2024 to Dec 1, 2025v6
  4. Primary and study completion dates: Jun 1, 2024 to Dec 1, 2024
    • Site contact updated
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2023 to Aug 2, 2023
    v4
  6. Re-verified, no change to tracked fieldsv3
  7. Primary endpoint revised
    • Secondary endpoints revised (8)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Chicago
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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.
Trial Details
NCT Number NCT05796752
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Skin-Picking, Trichotillomania (Hair-Pulling Disorder)
Related terms Excoriation Disorder, Trichotillomania
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov