Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
2 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2000
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 1, 2005
CompletedFirst Posted
Study publicly available on registry
July 11, 2005
CompletedMay 20, 2008
May 1, 2008
4.3 years
July 1, 2005
May 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Clinical Global Impressions Scale change scores (week 2 versus 22)
Week 2 to 22
Hair Pulling Scale change scores (week 0 versus 22)
Week 0 to 22
TTM Impact Scale change scores (week 0 versus 22)
Week 0 to 22
PITS (week 0 versus 22)
Week 0 to 22
NIMH Scale (week 0 versus 22)
Week 0 to 22
Secondary Outcomes (4)
HAM-D-17 (week 0 versus 22)
Week 0 to 22
BDI (week 0 versus 22)
Week 0 to 22
BAI (week 0 versus 22)
Week 0 to 22
Q-LES-Q (week 0 versus 22)
Week 0 to 22
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Pfizercollaborator
Study Sites (1)
Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, 02129, United States
Related Publications (1)
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.
PMID: 34582562DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Jenike, M.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2005
First Posted
July 11, 2005
Study Start
January 1, 2000
Primary Completion
April 1, 2004
Study Completion
August 1, 2004
Last Updated
May 20, 2008
Record last verified: 2008-05