Trial Information

Summary: Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in the Treatment of Body Dysmorphic Disorder

The purpose of this study is to determine whether the medication venlafaxine (Effexor), in combination with cognitive behavioral therapy (CBT), is effective in the treatment of Body Dysmorphic Disorder (BDD). Effexor is approved by the Food and Drug Administration (FDA) for the treatment of Depression, Generalized Anxiety Disorder and Social Phobia, but not for the treatment of BDD.

The program we are currently offering is a 2-phase study using a serotonin reuptake inhibitor (SRI) medication called Effexor in addition to psychotherapy. The first phase of the study is an open-label treatment (all participants will be receiving active study medication) of Effexor, lasting between 12 and 16 weeks. After completing Phase 1, study volunteers would stay on a stable dose of Effexor and enter the 2nd (psychotherapy) phase of the program. During the psychotherapy phase study volunteers have a 50% chance of receiving Cognitive Behavioral Therapy (CBT) focused on BDD and a 50% chance of receiving CBT focused on stress management. During this phase, study volunteers must attend 12 psychotherapy sessions spaced approximately one week apart, in all, lasting about 12 weeks.

Interested participants who are already on a stable dose of an SRI may be eligible to bypass Phase 1 and directly enter the psychotherapy phase (Phase 2) of the study.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

Men and women aged 16-65 years who have a primary diagnosis of Body Dysmorphic Disorder or it?s delusional variant (delusional disorder, somatic type). Study volunteers should be physically healthy without any serious medical, psychiatric, or neurological illnesses other than BDD. Parental Consent must be provided if participant is less than 18 years of age.

For study volunteers who enter directly into Phase 2, they must be on one of the following SRI medications for at least 8 weeks prior to entering the program: fluoxetine (Prozac), fluvoxamine (Luvox), venlafaxine (Effexor), clomipramine (Anafranil), paroxetine (Paxil), citalopram (Celexa) or sertraline (Zoloft).

Subjects should not be on any other forms of psychiatric medication other than an SRI; those on other medications must be willing to come off their medication. Please contact the Study Coordinator for further exclusion criteria.

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Trial listings updated: June 1, 2008 at 5:43:47 AM