Memantine in Body Focused Repetitive Behaviors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-07-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trichotillomania (Hair-Pulling Disorder) Dermatillomania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pill that contains no medicine

Memantine

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

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Cognition-enhancing medication

Interventions

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Placebo

Pill that contains no medicine

Intervention Type DRUG

Memantine

Cognition-enhancing medication

Intervention Type DRUG

Other Intervention Names

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no other name Namenda

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No