Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
NCT ID: NCT00118014
Last Updated: 2008-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2000-01-31
2004-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Sertraline
Habit Reversal Training
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Massachusetts General Hospital
Principal Investigators
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Michael Jenike, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, United States
Countries
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References
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Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
Other Identifiers
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98-09272
Identifier Type: -
Identifier Source: secondary_id
1999-P-003152
Identifier Type: -
Identifier Source: org_study_id