Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
|Impulse Control Disorders||Drug: Sertraline Behavioral: Habit Reversal Training||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania|
- Clinical Global Impressions Scale change scores (week 2 versus 22) [ Time Frame: Week 2 to 22 ]
- Hair Pulling Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- TTM Impact Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- PITS (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- NIMH Scale (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- HAM-D-17 (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- BDI (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- BAI (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
- Q-LES-Q (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118014
|United States, Massachusetts|
|Massachusetts General Hospital - OCD Clinic|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Michael Jenike, M.D.||Massachusetts General Hospital|