NCT00182507CompletedPhase 4
A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
Hamilton Health Sciences Corporation1 site in 1 country34 target enrollmentStarted: June 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Clinical Global Impression (CGI)-Improvement Scale ≤ 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Clinical Global Impression (CGI)-Improvement Scale ≤ 2
Secondary Outcomes
- CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
Investigators
Study Sites (1)
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