Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]
- Hair Pulling Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- TTM Impact Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- PITS (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- NIMH Scale (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- HAM-D-17 (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- BDI (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- BAI (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
- Q-LES-Q (week 0 versus 22) [ Time Frame: Week 0 to 22 ] [ Designated as safety issue: No ]
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients will have a DSM-IV diagnosis of TTM.
- TTM symptoms for at least 4 months.
- Scalp as primary site of hair pulling.
- HPS score greater than or equal to 15 OR TTM Impact Scale score greater than 30.
- Written informed consent.
- Men or women aged 18-65 years old.
- Females of childbearing potential must have a negative serum beta-HCG pregnancy test.
Exclusion Criteria:
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- History of seizure disorder.
- Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder.
- If there is a history of substance abuse, patients must be in remission at least 6 months.
- Past trials of sertraline.
- Currently being treated with behavioral therapy, specifically habit reversal training, for TTM.
- Other medications for medical disorders that may interact with sertraline.
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital - OCD Clinic | |
| Charlestown, Massachusetts, United States, 02129 | |
| Principal Investigator: | Michael Jenike, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Michael Jenike, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00118014 History of Changes |
| Other Study ID Numbers: | 1999-P-003152, 98-09272 |
| Study First Received: | July 1, 2005 |
| Last Updated: | May 19, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Trichotillomania Habit Reversal Training Sertraline Zoloft |
Additional relevant MeSH terms:
|
Impulse Control Disorders Trichotillomania Mental Disorders Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013