Milk Thistle in Body Dysmorphic Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/23/2019 |
| Start Date: | October 2016 |
| End Date: | October 2019 |
| Contact: | Sarah Redden, BA |
| Email: | sredden@uchicago.edu |
| Phone: | 7737029066 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Previous treatment with milk thistle
- Any history of psychiatric hospitalization in the past year
- Currently pregnant (confirmed by urine pregnancy test)
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-834-1325
University of Chicago One of the world's premier academic and research institutions, the University of...
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