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Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD

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ClinicalTrials.gov Identifier: NCT00579280
Recruitment Status : Unknown
Verified February 2009 by University of South Florida.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2007
Last Update Posted : January 17, 2011
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of South Florida

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 24, 2007
Last Update Posted Date January 17, 2011
Study Start Date  ICMJE July 2007
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
The primary outcome measure is the Clinician Global Improvement Scale for Anxiety Symptoms (CGI-21). [ Time Frame: This is an 8 week study. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Official Title  ICMJE 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.
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: quetiapine SR
    flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
  • Drug: divalproex sodium ER
    Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: Quetiapine SR
    Quetiapine SR
    Intervention: Drug: quetiapine SR
  • Active Comparator: Divalproex Sodium ER
    Divalproex Sodium ER
    Intervention: Drug: divalproex sodium ER
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00579280
Other Study ID Numbers  ICMJE AZ 1107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David V. Sheehan, MD, MBA, University of South Florida College of Medicine
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: David Sheehan, MD University of South Florida
PRS Account University of South Florida
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP