Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Anxiety Disorder
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring generalized anxiety disorder, pharmacotherapy, treatment refractory, double-blind
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Paroxetine CR and Placebo
Quetiapine and continued paroxetine CR
Eleven individuals were randomized to plaecbo augmentation of continued paroxetine CR at the week 10 dose level. In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
Eleven individuals were randomized to quetiapine augmentation of continued paroxetine CR at the week 10 dose level. In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.