Brief Title
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
Official Title
A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
Brief Summary
Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive
compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been
unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to
TTM, but is treated with a different class of medications than used in OCD, namely
antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine
in the treatment of hair pulling.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Clinical Global Impression (CGI)-Improvement Scale ≤ 2
Secondary Outcome
CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
Condition
Trichotillomania
Intervention
Olanzapine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
June 2000
Completion Date
March 2006
Eligibility Criteria
Inclusion Criteria:
- primary DSM-IV trichotillomania; CGI-Severity ≥ 4
Exclusion Criteria:
- Any other Axis I primary diagnosis; CGI-S < 4; current comorbid: OCD, MDD, alcohol or
substance abuse; lifetime hx of: schizophrenia, bipolar affective disorder or
dementia; current pregnancy/lactation; current suicidality or homicidality; major
medical problems or clinically unstable medical disease; hx of: seizures, stroke or
head trauma; prior use of neuroleptics
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Michael A Van Ameringen, MD, FRCPC, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00182507
Organization ID
00-167
Study Sponsor
Hamilton Health Sciences Corporation
Collaborators
Eli Lilly and Company
Study Sponsor
Michael A Van Ameringen, MD, FRCPC, Principal Investigator, Hamilton Health Science, McMaster Univeristy Medical Centre
Verification Date
March 2006