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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00113295
First received: June 7, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Drug: Paroxetine-CR
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Symptoms of generalized anxiety disorder

Secondary Outcome Measures:
  • Clinical global improvement

Estimated Enrollment: 80
Study Start Date: February 2004
Study Completion Date: November 2007
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). 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).

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113295

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Naomi M Simon, MD Massachusetts General Hospital
Principal Investigator: Kathryn Connors, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Naomi M. Simon, MD, Massachusetts General Hospital, Boston, MA 02114
ClinicalTrials.gov Identifier: NCT00113295     History of Changes
Other Study ID Numbers: 2003-P001805
Study First Received: June 7, 2005
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
generalized anxiety disorder
pharmacotherapy
treatment refractory
double-blind

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Paroxetine
Quetiapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 16, 2014