Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Massachusetts General Hospital |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00114127 |
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
Condition | Intervention | Phase |
---|---|---|
Anxiety Disorder |
Drug: duloxetine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome |
Estimated Enrollment: | 84 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors (SSRIs) and the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, for the treatment of social anxiety disorder, with paroxetine, sertraline and venlafaxine extended-release (XR), which are FDA approved for this indication. The newest SNRI, duloxetine, has been shown to be effective at doses of 60mg/day to 120mg/day for anxiety associated with depression, and is anticipated to be a broad spectrum agent for mood and anxiety disorders (Dunner, Goldstein, Mallinckrodt, Lu, & Detke, 2003). However, no data on the efficacy of duloxetine for Social Anxiety Disorder, nor guidance regarding time to response or predictors of response, is yet available. These questions are the focus of this proposal.
This is a two phase, 24-week research study in which participants who remain symptomatic at the end of one phase (6 weeks) enter into the next phase. In phase I, all participants receive 60mg/day of duloxetine (Cymbalta) for 6 weeks. Participants who continue to have anxiety symptoms will enter the 18-week Phase II, in which they continue taking 60 mg/day of duloxetine and they will also be randomly assigned (by chance, like a flip of a coin) to receive either an additional 60mg/day of duloxetine or placebo (contains no active medication).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Naomi M Simon, MD | Massachusetts General Hospital |
Responsible Party: | Center for Anxiety and Traumatic Stress Disorders ( Naomi Simon, M.D. ) |
Study ID Numbers: | 2004-P-001384 |
Study First Received: | June 13, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00114127 |
Health Authority: | United States: Institutional Review Board |
social anxiety disorder social phobia duloxetine |
serotonin norepinephrine reuptake inhibitor SNRI double blind |
Dopamine Anxiety Disorders Mental Disorders Norepinephrine |
Phobic Disorders Serotonin Duloxetine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |