Bipolar I Disorder Clinical Trial
Official title:
Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder
The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.
This open methods advancement study will randomize BD patients with clinically significant
symptoms to treatment with one of two mood stabilizers (MS), lithium [Li] or divalproex
[Div]. Those who develop protocol defined depression will then be randomized to a MS alone,
MS + quetiapine [QTP] or MS + lamotrigine [LTG]. A SMART strategy employs a rule for adding
new treatments based on each patient's current illness state and response during the trial,
mimicking the adaptive nature of treatment selection which occurs in clinical settings, but
in a controlled way which allows application of causal inference. By using early indices of
response to dynamically alter treatment decisions to improve outcome, SMART eliminates
unmeasured confounders associated with treatment decisions that are not randomized, as occurs
in data mining exercises and in other non-randomized decisions in studies which randomize one
variable at baseline. This sequential adaptive design represents a methodological innovation
in bipolar trial history which will have particular implications for effectiveness studies.
Specific Aim A.1: Assess the feasibility of a SMART design in the conduct of an effectiveness
study over 26 weeks in patients with BD (bipolar disorder).
Aim A.2 Compare the effectiveness of Li to Div as a primary component of treatment for BD
over 26 weeks.
Aim A.3: Assess the effectiveness of MS + QTP and MS + LTG versus MS in subjects who develop
depression.
A4. Exploratory Aims: 1.Determine the effects of ethnicity, language facility, education and
stress as moderators of treatment outcomes; 2. Explore the use of novel statistical
methodologies to more informatively characterize illness trajectories in response to the
interventions. In the aggregate these aims also will clarify whether the SMART confirms
results provided by traditional, single point randomized controlled trials (RCTs).
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