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Sponsors and Collaborators: |
Massachusetts General Hospital Pfizer |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00118014 |
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.
Condition | Intervention | Phase |
---|---|---|
Impulse Control Disorders |
Drug: Sertraline Behavioral: Habit Reversal Training |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania |
Enrollment: | 75 |
Study Start Date: | January 2000 |
Study Completion Date: | August 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital - OCD Clinic | |
Charlestown, Massachusetts, United States, 02129 |
Principal Investigator: | Michael Jenike, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Michael Jenike, MD ) |
Study ID Numbers: | 1999-P-003152, 98-09272 |
Study First Received: | July 1, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00118014 History of Changes |
Health Authority: | United States: Institutional Review Board |
Trichotillomania Habit Reversal Training Sertraline Zoloft |
Neurotransmitter Agents Impulse Control Disorders Mental Disorders Psychotropic Drugs Sertraline |
Trichotillomania Serotonin Uptake Inhibitors Serotonin Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Trichotillomania Serotonin Uptake Inhibitors Pharmacologic Actions |
Impulse Control Disorders Serotonin Agents Mental Disorders Therapeutic Uses Sertraline Central Nervous System Agents Antidepressive Agents |