Impulse Control Disorders Clinical Trial
Official title:
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.
The purpose of this study is to assess the extent of symptom remission in patients with
trichotillomania following treatment with sertraline and/or behavior therapy.
Following entry into the study, subjects will undergo a washout period if they are currently
taking a psychotropic medication (two weeks for psychotropic medications except for
fluoxetine, which requires a four-week washout). Subjects will then be given a single-blind
placebo for two weeks and assessed for symptom consistency.
Subjects will take sertraline or placebo in a double-blind design. Subjects will be assessed
with the Hamilton Rating Scale for Depression (HAM-D-17), Beck Depression Inventory (BDI),
Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale
(HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale
(PITS), National Institute of Mental Health (NIMH) Scale, and Quality of Life Enjoyment and
Satisfaction Questionnaire (Q-LES-Q) at the start of the washout period and at the end of
week two in order to be randomized into the study. Subject randomization to a treatment arm
will be based on the random table and in equal proportions.
Subject change scores will be assessed for the above scales, and change scores for the four
different treatment groups will be assessed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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