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
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118014

Locations
United States, Massachusetts
Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
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 April 17, 2014