Milk Thistle in Body Dysmorphic Disorder

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 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.

Timeline

Start

2016-10

Primary completion

2023-10

Completion

2023-10

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

Drugs

Indications