The 10-week, randomized, double-blind, placebo-controlled study will evaluate a 34 mg dose of NUPLAZID in MDD patients who failed to respond adequately to standard antidepressant therapy with either a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. The primary endpoint is the change from baseline in the total score of a scale called HAM-D.
The company initiated a Phase 2 study in patients with negative symptoms of schizophrenia a couple of weeks ago.
NUPLAZID is a non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist that preferentially targets 5-HT2A receptors while avoiding activity at common targets like dopamine. The FDA approved it in April for the treatment of Parkinson's disease psychosis.
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