Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-10-31
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Silymarin (Milk Thistle)
Each subject will have a 4 week treatment phase with milk thistle.
Milk Thistle
Placebo
4 week placebo phase before or after milk thistle phase depending on randomization.
Placebo
Interventions
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Milk Thistle
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Previous treatment with milk thistle
* Any history of psychiatric hospitalization in the past year
* Currently pregnant (confirmed by urine pregnancy test)
18 Years
65 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Jon E Grant, JD, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16-0642
Identifier Type: -
Identifier Source: org_study_id