A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

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Summary

A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia
Description

This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with schizophrenia using SEP-363856 (50 or 75 mg/day [ie, once daily]) versus placebo over a 4-week treatment period. Primary hypoathesis to be tested: H0: μSEP = μPBO versus H1: μSEP ≠ μPBO, where μSEP and μPBO are the mean changes from Baseline at Week 4 in PANSS total score for the SEP-363856 and placebo arms, respectively. Subjects who complete study SEP361-201 may be eligible to enroll in the open-label extension study SEP361-202.

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hope this makes it to the second phase and out soon…!!

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http://adisinsight.springer.com/drugs/800036955

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OOps second phase…!!!

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What’s different about this drug?
Please clarify

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its major target is negative symptoms of sz…!!! which iz rare…!!!

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Any news on the side effects?

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nope not yet…!!!

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If they’re testing it on acute phase and it fails, does it mean it will be discontinued even if it is potentially useful for negative symptoms? That’s what I fear right now.

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I hope this gets approved. But to overcome negative symptoms, you need a lot of positivity, not just meds. It’s possible to be happy without waiting for a miraculous med.

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