Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Paroxetine; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Male and female outpatients, age 18-72.

• Primary diagnosis of generalized anxiety disorder.

• Patients on concurrent benzodiazepines will be entered into the trial if they remain symptomatic despite stable doses for at least one month

Exclusion Criteria:

• Pregnant or lactating women or other women of child bearing potential not using acceptable means of birth control

• Patients with a primary diagnosis of major depression, dysthymia, panic disorder or social phobia.

• Patients with current or history of bipolar disorder, schizophrenia or other psychotic conditions

• Patients with post-traumatic stress disorder or obsessive-compulsive disorder current in the past 6 months.

• Patients with a history of alcohol or substance abuse or dependence within the last six months.

• Patients with significant unstable medical illness.

• Ongoing psychotherapy directed toward the treatment of generalized anxiety disorder.

• History of hypersensitivity to paroxetine CR, paroxetine or quetiapine.

• History of cataracts.

• Concurrent use of psychotropic medications including buspirone and antidepressants. Patients must have discontinued buspirone or antidepressant therapy at least two weeks prior to study entry, and fluoxetine at least four weeks prior, but no patient will be taken off effective medication.

• Concomitant use of herbs and dietary supplements with known psychotropic properties, including St John's Wort, Kava, Valerian, Gingko, Ginseng, ephedra and weight loss supplements. Other than such agents with known psychotropic properties, no over the counter medications are exclusionary.