Back to resultsOlanzapine in the Treatment of Hair Pulling (Trichotillomania)
Primary Purpose
Trichotillomania
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania
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
Sites / Locations
- Hamilton Health Sciences, McMaster University Medical Centre
Outcomes
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
Full Information
NCT ID
NCT00182507
First Posted
September 14, 2005
Last Updated
September 8, 2006
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00182507
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Eli Lilly and Company
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
34 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
Clinical Global Impression (CGI)-Improvement Scale ≤ 2
Secondary Outcome Measure Information:
Title
CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Van Ameringen, MD, FRCPC
Organizational Affiliation
Hamilton Health Science, McMaster Univeristy Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences, McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34582562
Citation
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.
Results Reference
derived
PubMed Identifier
20441724
Citation
Van Ameringen M, Mancini C, Patterson B, Bennett M, Oakman J. A randomized, double-blind, placebo-controlled trial of olanzapine in the treatment of trichotillomania. J Clin Psychiatry. 2010 Oct;71(10):1336-43. doi: 10.4088/JCP.09m05114gre. Epub 2010 Apr 20.
Results Reference
derived
Learn more about this trial
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
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