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Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118014
First Posted: July 11, 2005
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Massachusetts General Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
  • Hair Pulling Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • TTM Impact Scale change scores (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • PITS (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • NIMH Scale (week 0 versus 22) [ Time Frame: Week 0 to 22 ]

Secondary Outcome Measures:
  • HAM-D-17 (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • BDI (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • BAI (week 0 versus 22) [ Time Frame: Week 0 to 22 ]
  • Q-LES-Q (week 0 versus 22) [ Time Frame: Week 0 to 22 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Jenike, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00118014     History of Changes
Other Study ID Numbers: 1999-P-003152
98-09272
First Submitted: July 1, 2005
First Posted: July 11, 2005
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Massachusetts General Hospital:
Trichotillomania
Habit Reversal Training
Sertraline
Zoloft

Additional relevant MeSH terms:
Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs