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.

Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

Skin-Picking

Trichotillomania (Hair-Pulling Disorder)

Hair pulling disorder (i.e., trichotillomania, TTM) and skin picking disorder (SPD) are
often categorized under the umbrella term of BFRB disorders. These repetitive,
intentionally performed behaviors often cause noticeable cosmetic issues and may result
in clinically significant distress or functional impairment.

Behavioral therapy (BT) is generally regarded as the first-line treatment for BFRBs. One
type of BT is comprehensive behavioral treatment (ComB), a treatment that emphasizes
habit reversal training and various techniques that target specific BFRB triggers (e.g.,
sensory cues, such as pressure on the scalp; environmental cues, such as bright lights
and mirrors), including emotion dysregulation. The ComB protocol was methodically
developed based on expert consensus and demonstrated promising results in one single case
design study and a randomized controlled trial comparing it to a minimal attention
control condition.

Research has also found benefit of pharmacological agents in the treatment of BFRBs. Most
recently, a randomized controlled trial of memantine vs. placebo found statistically
significant improvements in disorder severity and life functioning in the memantine group
as compared to the placebo group.

Although there are emerging behavioral and psychopharmacological interventions for BFRBs,
the research is limited. Additionally, there are no studies comparing the efficacy of
first-line behavioral treatments to promising medication interventions for this class of
disorders. Given the serious personal consequences associated with trichotillomania and
skin picking disorder, there is substantial need for additional research to clarify the
best available treatments for BFRBs. Doing so would facilitate future research and the
development of refined treatment guidelines. Therefore, the current trial aims to compare
the efficacy of behavioral therapy and memantine in adults with trichotillomania and skin
picking disorder.

Memantine

ComB Behavioral Therapy

Single-Group Crossover Trial Comparing Behavioral Treatment to Memantine in Body Focused Repetitive Behaviors

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 on the NIMH Symptom Severity Scale (for Trichotillomania or Skin Picking). The
primary endpoints will be used to examine differential improvements for memantine vs. BT.
Total scores on the NIMH-TSS and NIMH-SPS range from 0-20, with higher scores
representing greater severity of trichotillomania/skin picking.

A clinician-rated measure to assess global improvement in symptoms. The scale ranges from
1 (Very much improved) to 7 (Very much worse). The results will be dichotomized as
improved (CGI-I score of 1 or 2) or not improved (CGI-I score of 3-7). The scale will be
assessed at the end of the memantine treatment, at the end of the washout period, and at
the end of the ComB therapy treatment.

Brief, self-report instrument for assessing repetitive hairpulling. Seven individual
items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived
control, and associated distress. Total scores range from 0-28, with higher scores
indicating greater severity of trichotillomania (TTM).The scale will be administered at
screening, the end of the memantine treatment, at the end of the washout period, and at
the end of the ComB therapy treatment.

Brief, self-report instrument for assessing repetitive skin picking. Seven individual
items, rated for severity from 0 to 4, assess urges to pick, actual picking, perceived
control, and associated distress. Total scores range from 0-28, with higher scores
indicating greater severity of skin picking disorder. The scale will be administered at
screening, the end of the memantine treatment, at the end of the washout period, and at
the end of the ComB therapy treatment.

A self-report assessment of patient perceived quality of life. Quality of Life Inventory
t-scores range from 1-77. Higher scores indicate a higher quality of life, whereas lower
scores indicate a lower quality of life. The scale will be administered at screening, the
end of the memantine treatment, at the end of the washout period, and at the end of the
ComB therapy treatment.

A self-report measure of functional impairment from TTM or SPD. SDS total scores range
from 0-30. Higher scores indicate greater functional impairment. The scale will be
administered at screening, the end of the memantine treatment, at the end of the washout
period, and at the end of the ComB therapy treatment.

A clinician-administered assessment of anxiety. HAM-A total scores range from 0-56.
Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety. The
scale will be administered at screening, the end of the memantine treatment, at the end
of the washout period, and at the end of the ComB therapy treatment.

A clinician-administered assessment of depression. HAM-D total scores range from 0-52.
Higher scores indicate higher levels of depression, with 0 being no symptoms of
depression. The scale will be administered at screening, the end of the memantine
treatment, at the end of the washout period, and at the end of the ComB therapy
treatment.

A self-report assessment of impulsivity. BIS total scores range from 30-120. Higher total
scores indicate higher impulsiveness. The scale will be administered at screening, the
end of the memantine treatment, at the end of the washout period, and at the end of the
ComB therapy treatment.

All subjects will receive 8-weeks of memantine treatment (10mg po qday for the first two
weeks, then 20 mg po qday for the remaining six weeks). After the 8-weeks of memantine
treatment, the dose will be discontinued. Then, after a 4-week washout period, all
subjects will receive 8-weeks of ComB therapy. Therapy will be once a week for 30
minutes. After the 8-weeks of ComB treatment, the therapy will be discontinued.

Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

About this trial

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Placebo

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