Status:
COMPLETED
Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
Lead Sponsor:
Stanford University
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar II Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 Seroq...
Detailed Description
Bipolar disorder is recognized as a severe and treatment-refractory illness. Recent work from multiple research centers in both Europe and the U.S. have found the percentage of patients experiencing h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00186043
Start Date
August 1 2008
End Date
August 1 2011
Last Update
September 27 2017
Active Locations (1)
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1
Terence Ketter
Stanford, California, United States, 94305