Trial Outcomes & Findings for Inositol in Trichotillomania (NCT NCT01875445)
NCT ID: NCT01875445
Last Updated: 2023-02-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Once every two weeks for the 10 weeks of the study
Results posted on
2023-02-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
12
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Inositol in Trichotillomania
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
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
n=19 Participants
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
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
28.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
28.9 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latino/Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
National Institute of Mental Health Trichotillomania Severity Scale
|
11.6 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Massachusetts General Hospital Hairpulling Scale
|
17.9 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
18.8 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
18.4 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
The Clinical Global Impressions Scale-Severity
|
4.2 units on a scale
STANDARD_DEVIATION .5 • n=5 Participants
|
4.5 units on a scale
STANDARD_DEVIATION .6 • n=7 Participants
|
4.4 units on a scale
STANDARD_DEVIATION .6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Once every two weeks for the 10 weeks of the studyPopulation: Last observation carried forward for general means.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
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
n=19 Participants
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.
|
|---|---|---|
|
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
|
8.4 units on a scale
Standard Deviation 5.5
|
8.4 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Once every two weeks for the 10 weeks of the studyPopulation: Last observation carried forwards for general averages.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
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
n=19 Participants
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.
|
|---|---|---|
|
The Massachusetts General Hospital (MGH) Hairpulling Scale
|
14.5 units on a scale
Standard Deviation 5.1
|
13.2 units on a scale
Standard Deviation 6.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Inositol
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=19 participants at risk
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
n=19 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=19 participants at risk
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
n=19 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Upset Stomach
|
10.5%
2/19 • Number of events 3
|
21.1%
4/19 • Number of events 6
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/19
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Headache
|
10.5%
2/19 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/19
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place