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

NCT ID: NCT00113295

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-11-30

Brief 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.

Detailed Description

Generalized anxiety disorder (GAD) is a relatively common condition affecting 5% of the population, with a typically chronic course and associated with significant psychosocial impairment and decreased quality of life (Schweizer, 1995). Although a number of therapeutic agents demonstrate some efficacy in the treatment of generalized anxiety disorder, only a minority of anxious patients experience remission with initial treatment.

The purpose of this study is to examine the efficacy of one strategy, the addition of quetiapine, for the treatment of patients with GAD who remain refractory despite an adequate treatment trial with a selective serotonin reuptake inhibitor (SSRI). This is an investigator-initiated augmentation study of an already approved drug for a different indication. Quetiapine is a novel antipsychotic agent with potent effects at the serotonergic, as well as dopaminergic receptor, and a more favorable side effect profile than standard neuroleptics, including a low potential to cause extrapyramidal symptoms.

This is a two phase, 18-week research study in which participants who remain symptomatic at the end of one phase (10 weeks) enter into the next phase. In phase I, all participants receive paroxetine CR (Paxil CR) for 10 weeks. Participants who continue to have anxiety symptoms will enter the 8-week Phase II, in which they continue taking Paxil CR and they will also be randomly assigned (by chance, like a flip of a coin) to receive quetiapine (Seroquel) or placebo (contains no active medication).

Conditions

Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paroxetine CR and Placebo

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.

Group Type: ACTIVE_COMPARATOR

Continued Paroxetine CR

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Quetiapine and continued paroxetine CR

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.

Group Type: EXPERIMENTAL

Continued Paroxetine CR

Intervention Type: DRUG

Quetiapine

Intervention Type: DRUG

Interventions

Continued Paroxetine CR

Intervention Type: DRUG

Quetiapine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Naomi M. Simon

Director, Center for Anxiety and Traumatic Stress Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naomi M Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Kathryn Connors, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Related Links

http://www.mghanxiety.org

The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital

Other Identifiers

2003-P001805

Identifier Type: -

Identifier Source: org_study_id