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

Completed · Phase 4 · Has a placebo group

Conditions studied: Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00113295

Run by

Massachusetts General Hospital

People needed

50

Starts

2004-02-01

Expected to finish

2007-11-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.