Olanzapine in the Treatment of Hair Pulling (Trichotillom... | NCT00182507

Studies
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)

NCT00182507

Sponsor

Hamilton Health Sciences Corporation

Status

Completed

Last Update Posted

Sep 11, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Trichotillomania

Interventions

Olanzapine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2000

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Global Impression (CGI)-Improvement Scale ≤ 2

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A Van Ameringen, MD, FRCPC	Hamilton Health Science, McMaster Univeristy Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences, McMaster University Medical Centre		Hamilton	Ontario	L8N 3Z5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34582562	Derived	Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
20441724	Derived	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. doi: 10.4088/JCP.09m05114gre. Epub 2010 Apr 20.

ID	Term
D009771	Obsessive-Compulsive Disorder
D001008	Anxiety Disorders
D001523	Mental Disorders
D007174	Disruptive, Impulse Control, and Conduct Disorders

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring