Olanzapine in the Treatment of Hair Pulling (Trichotillomania)

Trichotillomania Clinical Trial

Official title:

A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182507
• Other study ID #: 00-167
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: September 8, 2006
• Start date: June 2000
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, McMaster University Medical Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI)-Improvement Scale = 2
Secondary	CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale