AzTrials
AzTrials

Body Dysmorphic DisorderPhase 2NCT02843451

Milk Thistle in Body Dysmorphic Disorder

A Phase 2 study testing Milk Thistle in people with Body Dysmorphic Disorder, run by University of Chicago at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The proposed study will consist of a 9 week double-blind cross-over study trial of milk thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting of active treatment with milk thistle, and… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Body Dysmorphic Disorder
What is being tested?
Milk Thistle
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2016to Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females age 18-65
  • Diagnosis of current body dysmorphic disorder (BDD) based on DSM-5 criteria and confirmed using the clinician-administered Structural Clinical Interview for DSM-5 (SCID)
  • Able and willing to provide written consent for participation

Who cannot join

  • Unstable medical illness as determined by the investigator
  • History of seizures
  • Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale)
  • Baseline score greater than or equal to 17 on the Hamilton Depression Rating Scale (17-item HDRS)
  • Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder
  • Initiation of psychotherapy of behavior therapy within 3 months prior to study baseline
Show all 9Show fewer
  • Previous treatment with milk thistle
  • Any history of psychiatric hospitalization in the past year
  • Currently pregnant (confirmed by urine pregnancy test)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study

The proposed study will consist of a 9 week double-blind cross-over study trial of milk thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting of active treatment with milk thistle, and the other 4 week phase consisting of inactive placebo treatment. Participants will be randomized to receive either milk thistle or placebo during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

Read the detailed description

The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in adults with body dysmorphic disorder. The hypothesis to be tested is that silymarin will be more effective and well tolerated in adults with body dysmorphic disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using silymarin (milk thistle) in 15 participants with body dysmorphic disorder. The study will consist of three phases: a 4 week active treatment phase with milk thistle, a 4 week placebo phase, and a one week wash out phase between the active and placebo phases. The subjects will be randomized to either receive active or placebo treatment in the first 4 weeks, and the other during the remaining 4 week phase.

This will be one of few studies assessing the use of pharmacotherapy for the treatment of body dysmorphic disorder in adults. Assessing the efficacy and safety of silymarin (milk thistle), will help inform clinicians about additional treatment options for adults suffering from this disorder.

Being tested
Milk Thistle, Placebo
Medical subject headings
Body Dysmorphic Disorders

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 groups in NCT02843451
Study groupRoleWhat they receive
Silymarin (Milk Thistle)ExperimentalEach subject will have a 4 week treatment phase with milk thistle.
Receives: Drug: Milk Thistle
PlaceboPlacebo comparator4 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.

  1. Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

    The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will take the BDD-YBOCS. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses severity of body dysmorphic disorder symptoms.

    Measured: Baseline and 9 weeks

Secondary outcomes (4)

  1. Clinical Global Impression- Severity and Improvement (CGI)

    The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the CGI. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses overall disorder severity.

    Measured: Baseline and 9 weeks

  2. Sheehan Disability Scale (SDS)

    The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the SDS. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses the level of disability from body dysmorphic disorder (or target disorder)

    Measured: Baseline and 9 weeks

  3. Hamilton Anxiety Rating Scale (HAM-A)

    The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the HAM-A. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses level of anxiety.

    Measured: Baseline and 9 weeks

  4. Hamilton Depression Rating Scale (HAM-D)

    The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the HAM-D. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses level of depression.

    Measured: Baseline and 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Why it stopped: Focus on other studies

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843451
Sponsor's protocol ID
16-0642
Status last verified
Dec 2022
First submitted
21 Jul 2016
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Phillips KA, McElroy SL, Keck PE Jr, Pope HG Jr, Hudson JI. Body dysmorphic disorder: 30 cases of imagined ugliness. Am J Psychiatry. 1993 Feb;150(2):302-8. doi: 10.1176/ajp.150.2.302.

    PubMed 8422082

  • Buchanan BG, Rossell SL, Maller JJ, Toh WL, Brennan S, Castle DJ. Brain connectivity in body dysmorphic disorder compared with controls: a diffusion tensor imaging study. Psychol Med. 2013 Dec;43(12):2513-21. doi: 10.1017/S0033291713000421. Epub 2013 Mar 11.

    PubMed 23473554

  • Dunai J, Labuschagne I, Castle DJ, Kyrios M, Rossell SL. Executive function in body dysmorphic disorder. Psychol Med. 2010 Sep;40(9):1541-8. doi: 10.1017/S003329170999198X. Epub 2009 Dec 2.

    PubMed 19951448

  • Phillips KA, Albertini RS, Rasmussen SA. A randomized placebo-controlled trial of fluoxetine in body dysmorphic disorder. Arch Gen Psychiatry. 2002 Apr;59(4):381-8. doi: 10.1001/archpsyc.59.4.381.

    PubMed 11926939

  • Phillips KA. Pharmacologic treatment of body dysmorphic disorder: review of the evidence and a recommended treatment approach. CNS Spectr. 2002 Jun;7(6):453-60, 463. doi: 10.1017/s109285290001796x.

    PubMed 15107767

  • Yaghmaei P, Oryan S, Mohammadi K, Solati J. Role of serotonergic system on modulation of depressogenic-like effects of silymarine. Iran J Pharm Res. 2012 Winter;11(1):331-7.

    PubMed 24250456

  • Lu P, Mamiya T, Lu L, Mouri A, Niwa M, Kim HC, Zou LB, Nagai T, Yamada K, Ikejima T, Nabeshima T. Silibinin attenuates cognitive deficits and decreases of dopamine and serotonin induced by repeated methamphetamine treatment. Behav Brain Res. 2010 Mar 5;207(2):387-93. doi: 10.1016/j.bbr.2009.10.024. Epub 2009 Oct 24.

    PubMed 19857526

  • Seamans JK, Yang CR. The principal features and mechanisms of dopamine modulation in the prefrontal cortex. Prog Neurobiol. 2004 Sep;74(1):1-58. doi: 10.1016/j.pneurobio.2004.05.006.

    PubMed 15381316

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • Phillips KA, Hollander E, Rasmussen SA, Aronowitz BR, DeCaria C, Goodman WK. A severity rating scale for body dysmorphic disorder: development, reliability, and validity of a modified version of the Yale-Brown Obsessive Compulsive Scale. Psychopharmacol Bull. 1997;33(1):17-22.

    PubMed 9133747

  • HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

    PubMed 13638508

  • Burker EJ, Evon DM, Marroquin Loiselle M, Finkel JB, Mill MR. Coping predicts depression and disability in heart transplant candidates. J Psychosom Res. 2005 Oct;59(4):215-22. doi: 10.1016/j.jpsychores.2005.06.055.

    PubMed 16223624

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Milk Thistle in people with Body Dysmorphic 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Dec 2022. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) (time frame: Baseline and 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02843451, which also lists 12 linked publications.

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 28 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in