Trial Outcomes & Findings for Milk Thistle in Trichotillomania in Children and Adults (NCT NCT02473913)

Last Updated: 2020-11-20

Results Overview

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the NIMH-Trichotillomania Symptom Severity Scale (NIMH-TSS). The change in scores from baseline to after 13 weeks will be assessed. The NIMH-TSS consists of 5 questions related to the following aspects of TTM: average time spent pulling, time spent pulling on the previous day, resistance to urges, resulting distress and daily interference. NIMH-TSS scores range from 0 to 25, with higher scores indicating higher severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Baseline and 13 weeks

Results posted on

2020-11-20

Participant Flow

This is a crossover study. Therefore, only 22 participants were technically enrolled, but they each were supposed to complete both the placebo and the Milk Thistle Arm.

Participant milestones

Participant milestones
Measure	Experimental: Milk Thistle, Then Placebo Participants first received Milk Thistle for 6 weeks. After a washout period of 1 week, they then received matching Placebo for 6 weeks.	Experimetal: Placebo, Then Milk Thistle Participants first received matching Placebo for 6 weeks. After a washout period of 1 week, they then received matching Milk Thistle for 6 weeks.
Overall Study STARTED	11	11
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Milk Thistle, Then Placebo Participants first received Milk Thistle for 6 weeks. After a washout period of 1 week, they then received matching Placebo for 6 weeks.	Experimetal: Placebo, Then Milk Thistle Participants first received matching Placebo for 6 weeks. After a washout period of 1 week, they then received matching Milk Thistle for 6 weeks.
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Milk Thistle in Trichotillomania in Children and Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Milk Thistle, Then Placebo n=11 Participants Participants first received Milk Thistle for 6 weeks. After a washout period of 1 week, they then received matching placebo for 6 weeks.	Placebo, Then Milk Thistle n=11 Participants Participants first received matching placebo for 6 weeks. After a washout period of 1 week, they then received Milk Thistle for 6 weeks.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	27.7 years STANDARD_DEVIATION 11.1 • n=7 Participants	28.1 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 13 weeks

Outcome measures

Outcome measures
Measure	Milk Thistle n=17 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores Pre-Treatment	9.4 score on a scale Standard Deviation 5.4	9.4 score on a scale Standard Deviation 5.0
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores Post-Treatment	6.3 score on a scale Standard Deviation 5.3	7.4 score on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Up to 13 weeks

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the MGH-Hair Pulling Scale (MGH-HPS). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The MGH-HPS is a self report scale that assesses severity of Trichotillomania in the past week. There are seven total items each rated for severity from 0 to 4. Higher scores indicate higher symptom severity.

Outcome measures

Outcome measures
Measure	Milk Thistle n=17 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) Pre-Treatment	13.5 score on a scale Standard Deviation 6.8	14.7 score on a scale Standard Deviation 7.1
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) Post-Treatment	10.4 score on a scale Standard Deviation 7.6	12.3 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Up to 13 weeks

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the CGI. At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The CGI-Severity is rated on a 7-point scale, with the severity of illness ranging from 1 (normal) through 7 (among the most severely ill patients). CGI-Change scores range from 1 (very much improved) through 7 (very much worse).

Outcome measures

Outcome measures
Measure	Milk Thistle n=16 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Clinical Global Impression- Severity and Improvement (CGI) Pre-Treatment	4.1 score on a scale Standard Deviation 1.0	3.9 score on a scale Standard Deviation 0.6
Clinical Global Impression- Severity and Improvement (CGI) Post-Treatment	3.0 score on a scale Standard Deviation 1.4	3.6 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Up to 13 weeks

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Sheehan Disability Scale (SDS). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The scale itself assesses the level of functional impairment from trichotillomania (or target disorder). The subject is asked to rank the extent to which work/school, family life/home responsibilities, or social life are impaired by their symptoms on a scale from 0 (not at all) to 10 (extremely). The three numerical ratings can then be summed to produce a single measure of global functional impairment from 0 (unimpaired) to 30 (highly impaired).

Outcome measures

Outcome measures
Measure	Milk Thistle n=17 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Sheehan Disability Scale (SDS) Pre-Treatment	8.8 score on a scale Standard Deviation 8.0	8.8 score on a scale Standard Deviation 4.1
Sheehan Disability Scale (SDS) Post-Treatment	5.2 score on a scale Standard Deviation 7.8	5.9 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: Up to 13 weeks

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Hamilton Anxiety Rating Scale (HAM-A), a 14 item scale. At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Outcome measures

Outcome measures
Measure	Milk Thistle n=17 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Hamilton Anxiety Rating Scale (HAM-A) Pre-Treatment	4.9 score on a scale Standard Deviation 4.8	5.1 score on a scale Standard Deviation 4.4
Hamilton Anxiety Rating Scale (HAM-A) Post-Treatment	2.8 score on a scale Standard Deviation 3.5	3.4 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Up to 13 weeks

The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Hamilton Depression Rating Scale (HAM-D). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. Classification of symptoms are scored as follows: 0 - absent: 1 - doubtful or trivial: 2 - present. Classification of symptoms where more detail can be obtained can be expanded to: 0 - absent; 1 - mild; 2 - moderate; 3 - severe; 4 - incapacitating. In general the higher the total score the more severe the depression. HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.

Outcome measures

Outcome measures
Measure	Milk Thistle n=17 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=17 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Hamilton Depression Rating Scale (HAM-D) Pre-Treatment	5.7 score on a scale Standard Deviation 5.1	5.5 score on a scale Standard Deviation 4.4
Hamilton Depression Rating Scale (HAM-D) Post-Treatment	2.7 score on a scale Standard Deviation 3.3	2.9 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: For some subjects, the scale was not filled out at follow-up visits (in error).

The entire study for the subject will last 13 weeks. The subject will take the TSC-C (child version).The parent of the subject will fill out the TSC-P (parent version). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The scale itself assesses severity of trichotillomania and provides a sub score for severity. The severity score is produced by adding up the scores for questions 1 through 5 and dividing that sum by 5. The second sub score is on distress/impairment with questions such as "in the past week, how often did you feel like pulling your hair?". The sub score for distress/impairment is produced by adding the scores for questions 6-12 and dividing that sum by 7. The sum of both sub scores provides a total score. Total scores (ranging between 0 and 4) were compared pre treatment and post treatment. Higher scores indicate a higher severity and distress impairment score.

Outcome measures

Outcome measures
Measure	Milk Thistle n=3 Participants Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=3 Participants 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P) Pre-Treatment (TSC-C)	2.9 score on a scale Standard Deviation 0.3	2.0 score on a scale Standard Deviation 0.8
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P) Post-Treatment (TSC-C)	1.7 score on a scale Standard Deviation 1.1	1.7 score on a scale Standard Deviation 0.1
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P) Pre-Treatment (TSC-P)	2.5 score on a scale Standard Deviation 0.2	1.9 score on a scale Standard Deviation 0.1
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P) Post-Treatment (TSC-P)	1.1 score on a scale Standard Deviation 0	2.3 score on a scale Standard Deviation 0.2

Adverse Events

Milk Thistle

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Milk Thistle n=18 participants at risk Each subject will have a 6 week treatment phase with milk thistle. Milk Thistle	Placebo n=21 participants at risk 6 week placebo phase before or after milk thistle phase depending on randomization. Placebo
Gastrointestinal disorders Nausea	16.7% 3/18 • Number of events 3 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	9.5% 2/21 • Number of events 2 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
Gastrointestinal disorders Bloating	5.6% 1/18 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	4.8% 1/21 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	4.8% 1/21 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
General disorders Dry Mouth	0.00% 0/18 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	4.8% 1/21 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
Gastrointestinal disorders Flatulence	0.00% 0/18 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	4.8% 1/21 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
Nervous system disorders Headaches	5.6% 1/18 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	4.8% 1/21 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).
Nervous system disorders Insomnia	5.6% 1/18 • Number of events 1 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).	0.00% 0/21 • Adverse event data were collected at each study visit (Visits 1-8) over the subjects' study participation (13 weeks) and over the total course of the study (3 years).

Additional Information

Stephanie Valle

University of Chicago

Phone: 773-834-3778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place