Olanzapine in the Treatment of Hair Pulling (Trichotillomania)

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by:

McMaster University

ClinicalTrials.gov Identifier:

NCT00182507

First received: September 14, 2005

Last updated: September 8, 2006

Last verified: March 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 8, 2006

Start Date ^ICMJE

June 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Clinical Global Impression (CGI)-Improvement Scale ≤ 2

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00182507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Olanzapine in the Treatment of Hair Pulling (Trichotillomania)

Official Title ^ICMJE

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Trichotillomania

Intervention ^ICMJE

Drug: Olanzapine

Study Arm (s)

Not Provided

Publications *

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. Epub 2010 Apr 20.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00182507

Other Study ID Numbers ^ICMJE

00-167

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Michael A Van Ameringen, MD, FRCPC

Hamilton Health Science, McMaster Univeristy Medical Centre

Information Provided By

McMaster University

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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