Milk Thistle in Body Dysmorphic Disorder

Status Withdrawn

Clinical 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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02843451
Study type	Interventional
Source	University of Chicago
Contact
Status	Withdrawn
Phase	Phase 2
Start date	October 2016
Completion date	October 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02635152` - Interpretation Bias Modification for Body Dysmorphic Disorder	N/A
Completed	`NCT03673046` - Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)	N/A
Recruiting	`NCT05402475` - Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder	N/A
Completed	`NCT02010619` - Internet Delivered CBT for Body Dysmorphic Disorder	N/A
Completed	`NCT00842309` - D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder	Early Phase 1
Completed	`NCT00245635` - Fluoxetine in Pediatric Body Dysmorphic Disorder	Phase 4
Completed	`NCT02808702` - Brain Correlates of Self-Focused Processing	N/A
Completed	`NCT01002326` - Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder	N/A
Active, not recruiting	`NCT01075672` - Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals	N/A
Completed	`NCT02671266` - Oxytocin Administration in BDD and OCD	Phase 2
Completed	`NCT01038128` - An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder	N/A
Completed	`NCT01398865` - Escitalopram Neuroimaging Supplement	N/A
Completed	`NCT00265109` - Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder	Phase 4
Recruiting	`NCT04373629` - Perceptual Abnormalities and Their Malleability in BDD	N/A
Completed	`NCT01453439` - Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder	N/A
Completed	`NCT00871143` - Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)	N/A
Completed	`NCT00106223` - Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder	N/A
Active, not recruiting	`NCT00211809` - CBT as an Adjunct to SRIs in the Treatment of BDD	Phase 4