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Inositol in Trichotillomania

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ClinicalTrials.gov Identifier: NCT01875445
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

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
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Inositol
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 19 19
Completed 12 19
Not Completed 7 0
Reason Not Completed
Lost to Follow-up             5             0
Withdrawal by Subject             2             0
Arm/Group Title Placebo Inositol Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
29.8  (12.2) 28.0  (11.4) 28.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
18
  94.7%
17
  89.5%
35
  92.1%
Male
1
   5.3%
2
  10.5%
3
   7.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 19 participants 19 participants 38 participants
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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
National Institute of Mental Health Trichotillomania Severity Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
11.6  (3.4) 12.9  (3.7) 12.3  (3.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
17.9  (3.3) 18.8  (4.2) 18.4  (3.8)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
4.2  (.5) 4.5  (.6) 4.4  (.6)
[1]
Measure Description: A clinician rating of disorder severity with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
1.Primary Outcome
Title The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
Hide Description The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.
Time Frame Once every two weeks for the 10 weeks of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Last observation carried forward for general means.
Arm/Group Title Placebo Inositol
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.4  (5.5) 8.4  (5.1)
2.Secondary Outcome
Title The Massachusetts General Hospital (MGH) Hairpulling Scale
Hide Description The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the MGH Hairpulling Scale for the duration of the 10 weeks, baseline and final visits will be use for general final outcome assessment. The scale itself asses severity of hair pulling.
Time Frame Once every two weeks for the 10 weeks of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Last observation carried forwards for general averages.
Arm/Group Title Placebo Inositol
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.5  (5.1) 13.2  (6.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Inositol
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Placebo Inositol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Inositol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/19 (5.26%)    
Pregnancy, puerperium and perinatal conditions     
Ectopic Pregnancy [1]  0/19 (0.00%)  0 1/19 (5.26%)  1
[1]
Subject reported an ectopic pregnancy during the study. This was a possible side effect of the subject's birth control medication, and was thus unlikely to be related to the inositol treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Inositol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      9/19 (47.37%)    
Gastrointestinal disorders     
Nausea/Upset Stomach [1]  2/19 (10.53%)  3 4/19 (21.05%)  6
Stomach Pain [1]  0/19 (0.00%)  0 2/19 (10.53%)  2
Diarrhea  0/19 (0.00%)  0 2/19 (10.53%)  2
Gas  0/19 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Headache [1]  2/19 (10.53%)  2 2/19 (10.53%)  2
[1]
Mild severity.
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
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT01875445     History of Changes
Other Study ID Numbers: 2013InositolTTM
First Submitted: June 7, 2013
First Posted: June 11, 2013
Results First Submitted: February 27, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017