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An adaptive, phase IIB/III, double-blind, randomized, placebo-controlled, multi-center study of the safety and efficacy of NaBen® (sodium benzoate), a d-amino acid oxidase inhibitor, as an add-on treatment for schizophrenia in adolescents

Principal Investigator:
Robert
Findling

Phase IIb Objectives: The primary objective of the Phase IIb portion of this study is to evaluate NaBen® (sodium benzoate) (1000 mg/day) safety and effectiveness and to determine the final sample size needed in order to proceed with the Phase III part of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day). 

Phase III Objectives: The primary objective of the Phase III portion of this study is to evaluate the effectiveness of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day), in improving the negative and positive symptoms associated with schizophrenia in adolescents.

The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day). 

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