Comparative Effectiveness Study for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of lithium and quetiapine for the
      treatment of individuals with bipolar disorder.
    

Detailed description: 
      Mood stabilizers, medications that prevent future mood episodes, are the foundation for
      treatment of bipolar disorder. While all published bipolar disorder treatment guidelines
      recommend that pharmacotherapy should include mood stabilizers for long-term maintenance
      treatment, no randomized comparative effectiveness studies have examined the real-world
      advantages and disadvantages of the newer second generation antipsychotic (SGA) mood
      stabilizers compared to the classic mood stabilizers, such as lithium (Li). No studies have
      looked at the effectiveness of SGAs compared to mood stabilizers when used in the context of
      other medications required to manage bipolar patients, since bipolar disorder patients take a
      median of 3 medications for optimal outcomes. Quetiapine (QTP) is the most extensively
      studied, broadly efficacious and the most widely prescribed SGA for bipolar disorder. The
      classic mood stabilizer Li has the largest evidence base for treating bipolar disorder, but
      has been largely supplanted by the SGAs.

      Thus, this study compares symptomatic benefits and adverse effect burden between a QTP
      foundation with adjunctive personalized treatments (QTP+APT) and a mood stabilizer foundation
      consisting of Li with APT (Li+APT). APT will include any other medication needed with the
      following exceptions: the QTP+APT cannot receive Li and the Li+APT group cannot receive an
      antipsychotic. If, however, participants clinically require a switch to, or the addition of
      any other SGA or mood stabilizer, then those medications can be added as a rescue strategy
      that will be carefully recorded. Consistent with an effectiveness trial, participants will be
      able to continue in the study if they require a rescue treatment. The specific plan is a
      randomized, open, two arm, comparative effectiveness study of QTP+APT vs. Li+APT treatment
      for 6 months across 10 sites.

      In summary, this comparative effectiveness study compares fundamentally different acute and
      continuation treatments for bipolar disorder. The investigators address the key question of
      whether to use a prototypical mood stabilizing SGA (i.e., QTP) or the classical mood
      stabilizer Li as the foundational treatment in the context of other necessary adjunctive
      personalized treatments (APT).
    

Intervention name(s): Lithium; Quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): 600-900mg per day over 6 months; 100-800mg a day over 6 months
Other intervention name(s): Lithoboid, Eskalith; Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder; Comparative effectiveness trial; Lithium; Quetiapine