TrichotillomaniaPhase 2NCT02473913
Milk Thistle in Trichotillomania in Children and Adults
A Phase 2 study testing Milk Thistle in people with Trichotillomania and Hair Pulling Disorder, run by University of Chicago at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in children and adults with trichotillomania. The hypothesis to be tested is that silymarin will be more effective and well tolerated in children and adults with trichotillomania compared to placebo. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Trichotillomania, Hair Pulling Disorder
- What is being tested?
- Milk Thistle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ages 10-65.
- Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
- Hair-pulling behavior within 2 weeks prior to enrollment;
- Child able and willing to provide active assent for participation;
- Legal guardian available to provide consent for participation.
Who cannot join
- Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;
- Unstable medical illness as determined by the investigator;
- History of seizures;
- Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;
- Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
- Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
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- Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
- Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
- Previous treatment with milk thistle;
- Any history of psychiatric hospitalization in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silymarin Treatment of Trichotillomania in Children and Adults: A Double-Blind, Placebo-Controlled, Cross-Over Study
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in children and adults with trichotillomania. The hypothesis to be tested is that silymarin will be more effective and well tolerated in children and adults with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Read the detailed description
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally performed pulling that causes noticeable hair loss and results in clinically significant distress or functional impairment. Trichotillomania appears relatively common with an estimated prevalence between 1-3%. Data on the pharmacological treatment of trichotillomania is limited to case reports and conflicting double-blind studies of serotonin reuptake inhibitors. One positive double-blind study of N-acetyl cysteine in adults was not successful when examined for children and adolescents. Available data on the treatment of trichotillomania in children are therefore limited.
Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the seeds of milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related to the scavenging of free radicals and activation of anti-oxidative defenses: increases in cellular glutathione content and superoxide dismutase activity. Milk thistle has been used for a range of psychiatric disorders including methamphetamine abuse and obsessive compulsive disorder. The flavonoid complex silymarin in preclinical studies has been found to increase serotonin and dopamine levels in the cortex. In the frontal cortex one of the functions of dopamine is to increase the signal to noise ratio, increased dopamine correlating with increased frontal performance. Studies have shown that the higher cortical dopamine levels are associated with improved frontal cortical cognitive performance. Cortical inhibition is felt to be the basis for top-down control of motivated behaviors. A recent randomized controlled study with milk thistle was conducted in Iran Thirty five participants with moderate OCD were randomly assigned to 200 mg of milk thistle leaf extract or 10 mg of fluoxetine three times daily for eight weeks. Results revealed no significant difference in treatment effects between milk thistle and fluoxetine from baseline to endpoint as both interventions provided a highly significant reduction in symptoms. Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with trichotillomania.
The current pilot study examines the tolerability and efficacy of milk thistle in the treatment of trichotillomania in children and adults. The investigators hypothesize that milk thistle will reduce the severity of symptoms related to trichotillomania and improve patients' overall functioning.
- Conditions
- Trichotillomania, Hair Pulling Disorder
- Being tested
- Milk Thistle, Placebo
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk ThistleDrug
Also called Silymarin
PlaceboDrug
Also called Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Milk Thistle | Experimental | Each subject will have a 6 week treatment phase with milk thistle. Receives: Drug: Milk Thistle |
| Placebo | Placebo comparator | 6 week placebo phase before or after milk thistle phase depending on randomization. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores
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.
Measured: Baseline and 13 weeks
Secondary outcomes (6)
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
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.
Measured: Up to 13 weeks
Clinical Global Impression- Severity and Improvement (CGI)
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).
Measured: Up to 13 weeks
Sheehan Disability Scale (SDS)
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).
Measured: Up to 13 weeks
Hamilton Anxiety Rating Scale (HAM-A)
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.
Measured: Up to 13 weeks
Hamilton Depression Rating Scale (HAM-D)
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.
Measured: Up to 13 weeks
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P)
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.
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, JD, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473913
- Sponsor's protocol ID
- 15-0178
- Status last verified
- Nov 2020
- First submitted
- 2 Jun 2015
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silymarin Treatment of Trichotillomania in Children and Adults: A Double-Blind, Placebo-Controlled, Cross-Over Study
- ClinicalTrials.gov ID
- NCT02473913
- Acronym / sponsor ID
- 15-0178
- Conditions
- Trichotillomania, Hair Pulling Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in children and adults with trichotillomania. The hypothesis to be tested is that silymarin will be more effective and well tolerated in children and adults with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Detailed description
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally performed pulling that causes noticeable hair loss and results in clinically significant distress or functional impairment. Trichotillomania appears relatively common with an estimated prevalence between 1-3%. Data on the pharmacological treatment of trichotillomania is limited to case reports and conflicting double-blind studies of serotonin reuptake inhibitors. One positive double-blind study of N-acetyl cysteine in adults was not successful when examined for children and adolescents. Available data on the treatment of trichotillomania in children are therefore limited.
Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the seeds of milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related to the scavenging of free radicals and activation of anti-oxidative defenses: increases in cellular glutathione content and superoxide dismutase activity. Milk thistle has been used for a range of psychiatric disorders including methamphetamine abuse and obsessive compulsive disorder. The flavonoid complex silymarin in preclinical studies has been found to increase serotonin and dopamine levels in the cortex. In the frontal cortex one of the functions of dopamine is to increase the signal to noise ratio, increased dopamine correlating with increased frontal performance. Studies have shown that the higher cortical dopamine levels are associated with improved frontal cortical cognitive performance. Cortical inhibition is felt to be the basis for top-down control of motivated behaviors. A recent randomized controlled study with milk thistle was conducted in Iran Thirty five participants with moderate OCD were randomly assigned to 200 mg of milk thistle leaf extract or 10 mg of fluoxetine three times daily for eight weeks. Results revealed no significant difference in treatment effects between milk thistle and fluoxetine from baseline to endpoint as both interventions provided a highly significant reduction in symptoms. Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with trichotillomania.
The current pilot study examines the tolerability and efficacy of milk thistle in the treatment of trichotillomania in children and adults. The investigators hypothesize that milk thistle will reduce the severity of symptoms related to trichotillomania and improve patients' overall functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Thistle | Experimental | Drug: Milk ThistleEach subject will have a 6 week treatment phase with milk thistle. |
| Placebo | Placebo comparator | Drug: Placebo6 week placebo phase before or after milk thistle phase depending on randomization. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ages 10-65.
- Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
- Hair-pulling behavior within 2 weeks prior to enrollment;
- Child able and willing to provide active assent for participation;
- Legal guardian available to provide consent for participation.
Key exclusion criteria (10 listed)
- Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;
- Unstable medical illness as determined by the investigator;
- History of seizures;
- Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;
- Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk ThistleAlso: Silymarin | Drug | Milk Thistle |
| PlaceboAlso: Sugar Pill | Drug | Placebo |
Primary outcome
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores
Time frame: Baseline and 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 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.
6 secondary outcomes
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
Time frame: Up to 13 weeks
Clinical Global Impression- Severity and Improvement (CGI)
Time frame: Up to 13 weeks
Sheehan Disability Scale (SDS)
Time frame: Up to 13 weeks
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Up to 13 weeks
Hamilton Depression Rating Scale (HAM-D)
Time frame: Up to 13 weeks
Trichotillomania Scale for Children/Parent (TSC-C & TSC-P)
Time frame: Up to 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon E Grant, JD, MD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milk Thistle in people with Trichotillomania and Hair Pulling Disorder, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores (time frame: Baseline and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.