Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

NCT00118014

Last updated date
Study Location
Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, 02129, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impulse Control Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Impulse Control DisordersSertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
NCT00118014
  1. Charlestown, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
Official Title  ICMJE Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Impulse Control Disorders
Intervention  ICMJE
  • Drug: Sertraline
  • Behavioral: Habit Reversal Training
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2005)
75
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118014
Other Study ID Numbers  ICMJE 1999-P-003152
98-09272
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Jenike, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Michael Jenike, M.D.Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP