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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Corporation
Eli Lilly and Company
Investigators
Principal Investigator: Michael A Van Ameringen, MD, FRCPC Hamilton Health Science, McMaster Univeristy Medical Centre
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00182507     History of Changes
Other Study ID Numbers: 00-167
Study First Received: September 14, 2005
Last Updated: September 8, 2006
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014