Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
Condition: Bipolar II Disorder
MeSH terms: Mania
Intervention: Quetiapine/Seroquel; Placebo
Intervention description: Quetiapine/Seroquel; Placebo
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      1. The primary objective of this study is to examine the efficacy of quetiapine (Seroquel)
           in treatment of dysphoric hypomania in patients with Bipolar II disorder.

        2. To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and
           hypomanic symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet criteria for DSM-IV TR diagnosis of bipolar II disorder, as assessed by the
             structured clinical interview mood modules (SCID) (First et al., 1996).

          -  Must be hypomanic as rated by a >12 on the YMRS on two consecutive visits 1-3 days
             apart. And meet DSM IV TR criteria for hypomania

          -  Must be experiencing depressive symptoms as rated by > 14 on the MADRS rated at two
             consecutive visits 1-3 days apart and experiencing depressive symptoms for at least a
             seven-day period.

          -  Must be on stable medication regimens for at least two weeks, or on no medication at
             study entry.

          -  Must be men or women age 18-65 years of age.

          -  Must be able to give informed consent.

          -  Must be able to comprehend and satisfactorily comply with protocol requirements.

          -  If sexually active, females of child-bearing potential must be using a reliable method
             of contraception, which includes hormonal contraceptives, double-barrier methods
             (e.g., condom and foam, condom and diaphragm), intrauterine devices (IUD), or tubal
             ligation. Oral hormonal contraception is allowed as long as no other medications are
             being used that could decrease hormone levels and put the patient at risk for
             developing pregnancy.

        Exclusion Criteria:

          -  Receiving any atypical antipsychotics (washout period to be determined by treating
             psychiatrist)

          -  Receiving recognized antidepressant medication (within five half-lives), including
             serotonin reuptake inhibitors, venlafaxine, bupropion, or nefazodone.

          -  Receiving carbamazepine (within five half-lives).

          -  Experienced a hypomanic episode judged to be a direct physiological consequence of any
             medical condition or treatment, including neurological disorders, cardiovascular
             disease, metabolic or autoimmune conditions.

          -  Evidence that the patient is likely to need additional concomitant medical therapy
             during the trial.

          -  Participated in another trial of an investigational drug/device *or received clozapine
             within 30 days prior to baseline.

          -  Known hypersensitivity to Seroquel or any of its components.

          -  Known intolerability or past history of ineffectiveness of Seroquel.

          -  Met DSM-IV TR criteria for any substance or alcohol abuse or dependence disorder
             within the past month.

          -  History or evidence of unstable medical condition or known clinically significant
             abnormal laboratory results.

          -  Known or suspected chronic infectious disease including HIV or hepatitis.

          -  Women who are currently pregnant or desire to become pregnant during the study or
             women nursing an infant.

          -  Meet criteria for antisocial personality disorder.