Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

Impulse Control Disorders Clinical Trial

Official title:

Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118014
• Other study ID #: 1999-P-003152
• Secondary ID: 98-09272
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2005
• Last updated: May 19, 2008
• Start date: January 2000
• Est. completion date: August 2004

Study information

• Verified date: May 2008
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impulse Control Disorders
• Trichotillomania

Intervention

Drug:
• Sertraline

Behavioral:
• Habit Reversal Training

Locations

Country	Name	City	State
United States	Massachusetts General Hospital - OCD Clinic	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions Scale change scores (week 2 versus 22)		Week 2 to 22	No
Primary	Hair Pulling Scale change scores (week 0 versus 22)		Week 0 to 22	No
Primary	TTM Impact Scale change scores (week 0 versus 22)		Week 0 to 22	No
Primary	PITS (week 0 versus 22)		Week 0 to 22	No
Primary	NIMH Scale (week 0 versus 22)		Week 0 to 22	No
Secondary	HAM-D-17 (week 0 versus 22)		Week 0 to 22	No
Secondary	BDI (week 0 versus 22)		Week 0 to 22	No
Secondary	BAI (week 0 versus 22)		Week 0 to 22	No
Secondary	Q-LES-Q (week 0 versus 22)		Week 0 to 22	No