Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

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.