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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2004

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.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
• Behavioral: Habit Reversal Training

Primary Measures

• Clinical Global Impressions Scale change scores (week 2 versus 22)
  • Time Frame: Week 2 to 22
    Safety Issue?: No
• Hair Pulling Scale change scores (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• TTM Impact Scale change scores (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• PITS (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• NIMH Scale (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No

Secondary Measures

• HAM-D-17 (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• BDI (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• BAI (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: No
• Q-LES-Q (week 0 versus 22)
  • Time Frame: Week 0 to 22
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Michael Jenike, M.D. Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00118014

Study ID Number: 1999-P-003152

ClinicalTrials.gov Identifier: NCT00118014

Health Authority: United States: Institutional Review Board