Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00118014
First received: July 1, 2005
Last updated: May 19, 2008
Last verified: May 2008

July 1, 2005
May 19, 2008
January 2000
April 2004   (final data collection date for primary outcome measure)
  • 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 ]
  • Clinical Global Impressions Scale change scores (wk 2 v. 22)
  • Hair Pulling Scale change scores (wk 0 v. 22)
  • TTM Impact Scale change scores (wk 0 v. 22)
  • PITS (wk 0 v. 22)
  • NIMH Scale (wk 0 v. 22)
Complete list of historical versions of study NCT00118014 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HAM-D-17 (wk 0 v. 22)
  • BDI (wk 0 v. 22)
  • BAI (wk 0 v. 22)
  • Q-LES-Q (wk 0 v. 22)
Not Provided
Not Provided
 
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Impulse Control Disorders
  • Drug: Sertraline
  • Behavioral: Habit Reversal Training
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
August 2004
April 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118014
1999-P-003152, 98-09272
No
Michael Jenike, MD, Massachusetts General Hospital
Massachusetts General Hospital
Pfizer
Principal Investigator: Michael Jenike, M.D. Massachusetts General Hospital
Massachusetts General Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP