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Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

Primary Purpose

Impulse Control Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Habit Reversal Training
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulse Control Disorders focused on measuring Trichotillomania, Habit Reversal Training, Sertraline, Zoloft

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital - OCD Clinic

Outcomes

Primary Outcome Measures

Clinical Global Impressions Scale change scores (week 2 versus 22)
Hair Pulling Scale change scores (week 0 versus 22)
TTM Impact Scale change scores (week 0 versus 22)
PITS (week 0 versus 22)
NIMH Scale (week 0 versus 22)

Secondary Outcome Measures

HAM-D-17 (week 0 versus 22)
BDI (week 0 versus 22)
BAI (week 0 versus 22)
Q-LES-Q (week 0 versus 22)

Full Information

First Posted
July 1, 2005
Last Updated
May 19, 2008
Sponsor
Massachusetts General Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00118014
Brief Title
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
Official Title
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulse Control Disorders
Keywords
Trichotillomania, Habit Reversal Training, Sertraline, Zoloft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Type
Behavioral
Intervention Name(s)
Habit Reversal Training
Primary Outcome Measure Information:
Title
Clinical Global Impressions Scale change scores (week 2 versus 22)
Time Frame
Week 2 to 22
Title
Hair Pulling Scale change scores (week 0 versus 22)
Time Frame
Week 0 to 22
Title
TTM Impact Scale change scores (week 0 versus 22)
Time Frame
Week 0 to 22
Title
PITS (week 0 versus 22)
Time Frame
Week 0 to 22
Title
NIMH Scale (week 0 versus 22)
Time Frame
Week 0 to 22
Secondary Outcome Measure Information:
Title
HAM-D-17 (week 0 versus 22)
Time Frame
Week 0 to 22
Title
BDI (week 0 versus 22)
Time Frame
Week 0 to 22
Title
BAI (week 0 versus 22)
Time Frame
Week 0 to 22
Title
Q-LES-Q (week 0 versus 22)
Time Frame
Week 0 to 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jenike, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital - OCD Clinic
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34582562
Citation
Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
Results Reference
derived

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Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

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