Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Condition: Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Bipolar Disorder; Panic Disorder
Intervention: quetiapine SR; divalproex sodium ER; placebo
Intervention description: flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks; Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks; placebo
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Randomized; Double-Blind; Placebo-Controlled; Quetiapine; DivalproexSodiumER; Bipolar; Anxiety; Panic; GAD

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age and not older than 65

          -  Subjects must have lifetime bipolar I, II, or not otherwise specified (NOS) disorder
             as defined by DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, 4th
             Edition, Text Revision) 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