Trial of Aripiprazole in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier:
NCT00947154
First received: July 23, 2009
Last updated: May 31, 2015
Last verified: May 2015
Results First Received: April 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Trichotillomania
Interventions: Drug: aripiprazole
Drug: Aripiprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Open-label Aripiprazol Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.

Participant Flow:   Overall Study
    Open-label Aripiprazol  
STARTED     12  
COMPLETED     11  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Open-label Aripiprazol Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.

Baseline Measures
    Open-label Aripiprazol  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  34.0  (10.4)  
Gender  
[units: participants]
 
Female     12  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Mass General Hair Pulling Scale   [ Time Frame: Change from baseline to week 8 ]

2.  Primary:   Mass General Hair Pulling Scale, Actual Pulling Subscale   [ Time Frame: change from baseline to end of week 8 ]

3.  Secondary:   CGI-I Score of 1 or 2 (Very Much or Much Improved)   [ Time Frame: At week 8 ]

4.  Secondary:   Clinical Global Impressions Improvement (CGI-I)   [ Time Frame: At week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Matthew White, M.D., clinical assistant professor
Organization: Stanford Medical Center, Department of Psychiatry
phone: 650 725-5598
e-mail: mpwhite@stanford.edu


Publications of Results:

Responsible Party: Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier: NCT00947154     History of Changes
Other Study ID Numbers: SU-07172009-3320, eProtocol #15291
Study First Received: July 23, 2009
Results First Received: April 19, 2015
Last Updated: May 31, 2015
Health Authority: United States: Institutional Review Board