Table 2.

Overview of three 52-week clinical trials investigating the efficacy and safety of brexpiprazole for the maintenance treatment of schizophrenia

ClinicalTrials.gov ID Study	Study design	Number of participants	Average dose (mg)	Comments
NCT01668797 Fleischhacker et al8	Phase III multiple-phase study: • 1- to 4-week open-label conversion phase (if necessary) • 12- to 36-week single-blind stabilization phase • 52-week double-blind placebo-controlled maintenance phase	524 enrolled 202 entered randomized placebo- controlled phase	3.6	Trial was terminated at an interim analysis after 45 impending relapse events had occurred
NCT01397786 (also enrolled patients from NCT01668797, NCT01396421, and NCT01393613) Forbes et al10	Phase III open-label safety and tolerability study: • 1- to 4-week open-label conversion phase (if necessary) • 52-week open-label phase Following an amendment, the 52-week open-label phase was shortened to 26 weeks based on cumulative safety data from ongoing and current brexpiprazole studies	1,044 entered the 52- week open-label phase	3.0	952 were enrolled when the duration of open-label phase was 52 weeks; another 120 were enrolled when the duration was shortened to 26 weeks 409 participants (43% of those enrolled for 52 weeks) completed the trial 99 participants (82.5% of those enrolled for 26 weeks) completed the trial
NCT01456897 (also enrolled patients from NCT01451164) Ishigooka et al9	Phase III open-label safety and tolerability study: • 1- to 4-week open-label conversion phase (if necessary) • 52-week open-label phase	282 entered the 52- week open-label phase	3.1	Trial was not terminated early There was no maximum age cap 150 participants completed the 52-week open-label phase (53.4% of safety population)