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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00182507 |
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Date of registration:
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14/09/2005 |
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Primary sponsor: |
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Public title:
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Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
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Scientific title:
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A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania |
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Date of first enrolment:
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June 2000 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00182507 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Michael A Van Ameringen, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamilton Health Science, McMaster Univeristy Medical Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trichotillomania
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Intervention(s)
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Drug: Olanzapine
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Primary Outcome(s)
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Clinical Global Impression (CGI)-Improvement Scale = 2
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Secondary Outcome(s)
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CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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