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N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00354770
First received: July 18, 2006
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Trichotillomania
Interventions: Drug: Placebo
Drug: N-Acetyl Cysteine

  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
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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
N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Placebo Placebo pills

Participant Flow:   Overall Study
    N-Acetyl Cysteine   Placebo
STARTED   25   25 
COMPLETED   22   22 
NOT COMPLETED   3   3 



  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
N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Placebo Placebo pills
Total Total of all reporting groups

Baseline Measures
   N-Acetyl Cysteine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   25   25   50 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.8  (13.6)   32.7  (10.5)   34.5  (11.5) 
Gender 
[Units: Participants]
     
Female   24   21   45 
Male   1   4   5 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures

1.  Primary:   Massachusetts General Hospital Hairpulling Scale   [ Time Frame: Beginning to end of study every 2 weeks. ]


  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: Jon E. Grant
Organization: University of Chicago
phone: 773-834-1325
e-mail: jongrant@uchicago.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00354770     History of Changes
Other Study ID Numbers: 0604M85110
Study First Received: July 18, 2006
Results First Received: March 1, 2012
Last Updated: July 28, 2016
Health Authority: United States: Institutional Review Board