Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Pfizer
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00118014

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 IV

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

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

Responsible Party:	Massachusetts General Hospital ( Michael Jenike, MD )
Study ID Numbers:	1999-P-003152, 98-09272
Study First Received:	July 1, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00118014
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Trichotillomania
Habit Reversal Training
Sertraline
Zoloft

Study placed in the following topic categories:

Impulse Control Disorders
Mental Disorders
Sertraline
Trichotillomania
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009