Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Completed
CT.gov ID
NCT00182507
Collaborator
Eli Lilly and Company (Industry)
34
1
69
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
Study Start Date
:
Jun 1, 2000
Study Completion Date
:
Mar 1, 2006
Outcome Measures
Primary Outcome Measures
- Clinical Global Impression (CGI)-Improvement Scale ≤ 2 []
Secondary Outcome Measures
- CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton Health Sciences, McMaster University Medical Centre | Hamilton | Ontario | Canada | L8N 3Z5 |
Sponsors and Collaborators
- Hamilton Health Sciences Corporation
- Eli Lilly and Company
Investigators
- Principal Investigator: Michael A Van Ameringen, MD, FRCPC, Hamilton Health Science, McMaster Univeristy Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00182507
Other Study ID Numbers:
- 00-167
First Posted:
Sep 16, 2005
Last Update Posted:
Sep 11, 2006
Last Verified:
Mar 1, 2006