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Inositol in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT01875445
First received: June 7, 2013
Last updated: April 10, 2017
Last verified: April 2017
Results First Received: February 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Trichotillomania
Hair Pulling
Interventions: Drug: Inositol
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Placebo

Matched dosage of inositol daily.

Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Inositol

Powder form, 2g TID up to 6g TID

Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.


Participant Flow:   Overall Study
    Placebo   Inositol
STARTED   19   19 
COMPLETED   12   19 
NOT COMPLETED   7   0 
Lost to Follow-up                5                0 
Withdrawal by Subject                2                0 



  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.
No text entered.

Reporting Groups
  Description
Placebo

Matched dosage of inositol daily.

Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Inositol

Powder form, 2g TID up to 6g TID

Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Total Total of all reporting groups

Baseline Measures
   Placebo   Inositol   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.8  (12.2)   28.0  (11.4)   28.9  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  94.7%      17  89.5%      35  92.1% 
Male      1   5.3%      2  10.5%      3   7.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White      17  89.5%      18  94.7%      35  92.1% 
African American      2  10.5%      0   0.0%      2   5.3% 
Latino/Hispanic      0   0.0%      1   5.3%      1   2.6% 
Region of Enrollment 
[Units: Participants]
     
United States   19   19   38 
National Institute of Mental Health Trichotillomania Severity Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.6  (3.4)   12.9  (3.7)   12.3  (3.6) 
[1] A standard clinician administered scale to assess trichotillomania symptom severity. Scale range of 0-25. Higher scores indicate greater severity.
Massachusetts General Hospital Hairpulling Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.9  (3.3)   18.8  (4.2)   18.4  (3.8) 
[1] A standard self-report scale to assess trichotillomania symptom severity. Scale range of 0-28. Higher scores indicate greater severity.
The Clinical Global Impressions Scale-Severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.2  (.5)   4.5  (.6)   4.4  (.6) 
[1] A clinician rating of disorder severity with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).


  Outcome Measures
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1.  Primary:   The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)   [ Time Frame: Once every two weeks for the 10 weeks of the study ]

2.  Secondary:   The Massachusetts General Hospital (MGH) Hairpulling Scale   [ Time Frame: Once every two weeks for the 10 weeks of the study ]


  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: Dr. Jon Grant
Organization: University of Chicago
phone: 773-834-3778
e-mail: jongrant@uchicago.edu



Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT01875445     History of Changes
Other Study ID Numbers: 2013InositolTTM
Study First Received: June 7, 2013
Results First Received: February 27, 2017
Last Updated: April 10, 2017