Olanzapine in the Treatment of Hair Pulling (Trichotillomania) - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences Eli Lilly and Company
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182507

Purpose

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	Intervention	Phase
Trichotillomania	Drug: Olanzapine	Phase IV

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania

Further study details as provided by McMaster University:

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

Estimated Enrollment:	34
Study Start Date:	June 2000
Estimated Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182507

Locations

Canada, Ontario
Hamilton Health Sciences, McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5

Sponsors and Collaborators

Hamilton Health Sciences

Eli Lilly and Company

Investigators

Principal Investigator:

Michael A Van Ameringen, MD, FRCPC

Hamilton Health Science, McMaster Univeristy Medical Centre

More Information

Study ID Numbers:	00-167
Study First Received:	September 14, 2005
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00182507
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Impulse Control Disorders
Mental Disorders
Olanzapine
Trichotillomania
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009