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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


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
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