Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

Massachusetts General Hospital75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Impulse Control Disorders

Interventions

SertralineDRUG

Habit Reversal TrainingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital - OCD Clinic

Charlestown, Massachusetts, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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