Overview

This trial is active, not recruiting.

Conditions bipolar disorder, panic disorder, generalized anxiety disorder
Treatments quetiapine sr, divalproex sodium er, placebo
Phase phase 4
Sponsor University of South Florida
Collaborator AstraZeneca
Start date July 2007
End date May 2010
Trial size 90 participants
Trial identifier NCT00579280, AZ 1107

Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Quetiapine SR
quetiapine sr
flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
(Active Comparator)
Divalproex Sodium ER
divalproex sodium er
Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
(Placebo Comparator)
placebo
placebo
placebo

Primary Outcomes

Measure
The primary outcome measure is the Clinician Global Improvement Scale for Anxiety Symptoms (CGI-21).
time frame: This is an 8 week study.

Secondary Outcomes

Measure
Sheehan Panic Disorder Scale (SPS), (HAM-A), Young Mania Rating Scale (YMRS), Sheehan Irritability Scale (SIS), Rapid Ideas Scale RISC, MADRS, PGI-21 for anxiety symptoms, CGI-BP, Family Impact Scale (FIS), Sheehan Disability Scale (SDS).
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Subjects must be at least 18 years of age and not older than 65 - Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria - Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) - Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 - Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 - Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline - Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained - If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Exclusion Criteria: - Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria - Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria - Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication - Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP>5) - Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S<3) - Subjects with clinically significant suicidal or homicidal ideation. - Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) - Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months - Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests - Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to either of the active study medications - Women who are pregnant or nursing - Subjects who have received an experimental drug or used an experimental device within 30 days - Subjects who have a history of neuroleptic malignant syndrome - A patient with diabetes mellitus (DM) fulfilling one of the following criteria: - Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5% - Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks - Not under physician care for DM - Physician responsible for patient's DM care has not indicated that the patient's DM is controlled - Physician responsible for patient's DM care has not approved the patient's participation in the study - Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization - Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled Study of Quetiapine SR and Divalproex Sodium ER on Anxiety in Bipolar Disorder With at Least Moderately Severe Current Anxiety and Lifetime Panic or Generalized Anxiety Disorder.
Principal investigator David Sheehan, MD
Description This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 180 subjects will be randomized to obtain 90 subjects who complete the 8-week trial (30 completers per treatment group). This calculation is based on drop out rates in a similar patient population carried out by this group of collaborators. Subjects will be randomized to quetiapine SR or divalproex sodium ER or placebo in a 1:1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by University of South Florida.