Bipolar Disorder With Manic or Mixed Episodes Clinical Trial
Official title:
A Multicenter, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 1003 for the Treatment of Patients With Bipolar I Disorder Suffering Acute Manic or Mixed Episodes
The purpose of this study is to establish the potential of MEM 1003 as a safe and effective treatment for patients with an acute manic or mixed episode of bipolar disorder.
Bipolar affective disorder is one of the most common, severe, and persistent mental
illnesses. It is characterized by periods of deep, prolonged, and profound depressions that
alternate with periods of excessively elevated and/or irritable mood (mania). The
pathophysiology of bipolar disorder is complex, and can include an inheritable component,
administration of antidepressant medications, behavioral sensitization processes, and
neuronal calcium dysregulation that leads to apoptosis of critical brain circuitry that
regulates emotion. Addressing the dysregulation in calcium levels in the central nervous
system by administering compounds such as MEM 1003 may have the potential for altering the
cyclical course or progression of bipolar disorder.
MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central
nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human
dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel
modulators.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment