Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
Condition: Bipolar II Disorder
MeSH terms: Mania
Study type: Interventional
Phase: Phase 4

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.
    

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 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.
    

Intervention name(s): Quetiapine/Seroquel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine/Seroquel; Placebo
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment