Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorder
Intervention: Continued Paroxetine CR (Drug); Quetiapine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Naomi M Simon, MD, Principal Investigator, Affiliation: Massachusetts General Hospital Kathryn Connors, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.
Secondary outcome: Remission (HAM-A ≤ 7)Response, Clinical Global Impression of Improvement (CGI-I) Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS) The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 72 Years.
Gender(s): Both.
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.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Starting date: February 2004
Last updated: March 20, 2014
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