Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
- 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.
- To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Trial of Seroquel for the Treatment of Dysphoric Hypomania in Bipolar II Patients|
- CGI-BD Overall Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]change from baseline to endpoint in CGI-BD Overall Severity
- MADRS (Montgomery Asberg Depression Rating Scale) and YMRS (Young Mania Rating Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in MADRS and YMRS
|Study Start Date:||August 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Quetiapine/Seroquel up to 800 mg/day
Other Name: Quetiapine/Seroquel
Placebo Comparator: Placebo
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 hypomania that are also experiencing depressive symptoms is substantial. In a recent Stanley Foundation Bipolar Network study, it was found that 60% of all visits with at least moderate hypomania were associated with depressive symptoms. It is generally agreed that patients experiencing mixed states or combinations of mania with depressive symptoms are less responsive to older treatments such as lithium (Swann et al., 1997). We propose evaluating the response to Seroquel add-on versus placebo add-on for those patients experiencing hypomania and depressive symptoms, either simultaneously or closely juxtaposed within a 2-3 day period.
Bipolar II (BDII) patients make up a substantial percentage of patients with bipolar disorder, estimated conservatively at 0.5% of the US population and, with somewhat more liberal definitions of hypomania minimum duration, in Europe at 1% or greater. Importantly, few to virtually no recent treatment trials of high quality have been undertaken in BDII. Treatment guidelines and algorithms for bipolar disorder have been unable to specify defined treatments for BDII due to the lack of studies. Juxtaposed to the limits of controlled data, preliminary case series and clinical experience support atypical antipsychotics will be helpful for BDII patients. Thus the impact is high for a placebo controlled study of Seroquel in BDII.
We believe that this study is important to undertake because of the limited controlled data available for the treatment and management of patients with bipolar II disorder in outpatient settings. Numerous placebo-controlled monotherapy studies have been completed in inpatient settings for bipolar I, many leading to FDA submissions for registration. Maintenance trials are underway or are being developed for bipolar I disorder. There are no medications specifically approved for use in bipolar II patients at this time.
Additionally, the initial trials for the registration of Seroquel for bipolar disorder did not include patients with mixed symptoms. Clear cut-offs were provided in order to minimize the likelihood that patients with mixed symptoms would enter these trials. Thus, the trial proposed will provide data useful to the clinician in a real world setting, as well as provide data in an area not previously covered by the trial registration studies. We hypothesize that Seroquel will be effective to treat such symptoms in patients with BDII.
A clinically important and ground breaking aspect of the proposed trial is the focus on patients with bipolar II disorder. There is a paucity of data available to evaluate the use of atypical antipsychotics in patients with bipolar II disorder. Preliminary data of any sort in this area will be clinically useful, set the stage for larger more definitive trials, and translate readily into practice.
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Terence Ketter, MD||Stanford University|