An Ongoing Randomized Double-blind Active-controlled Study of Starting Aripiprazole Lauroxil with a 1-Day Initiation Regimen in Acutely Ill Subjects with Schizophrenia: Rationale, Study Design, and Patient Population at Baseline

 Recent FDA approvals provide physicians the opportunity to initiate long-acting injectable (LAI) antipsychotics in acute settings, but there is limited research comparing the efficacy and safety of different LAIs. In an ongoing multicenter, randomized, double-blind study, two LAI regimens are started in the hospital with continued outpatient follow-up: aripiprazole lauroxil (AL) using a 1-day initiation regimen or paliperidone palmitate (PP) using the initiation regimen of PP234mg/PP156mg a week apart.
Subjects receive a blinded IM injection at day 1 (ARISTADA INITIO or PP234mg), and the AL group also receive a blinded single 30mg oral aripiprazole dose. A week later, all subjects receive a second blinded IM injection, either the first dose of the 2-month AL dose (AL1064mg) or the second PP initiation dose (PP156mg). Subjects are discharged after 2-3 weeks and continue with blinded LAI injections in outpatient visits for six months. Patients received an additional 5 blinded injections every 4 weeks; either PP 156mg or AL 1064mg alternating with placebo. Primary outcomes include changes from baseline in PANSS (total score) at Week 4 for each treatment group and standard safety measures.
As of July 2018, 166 subjects have been randomized. Baseline characteristics reveal a sample of mostly men (74%) in their mid-40’s (mean 44 years), with 41% having not taken any antipsychotic for the month before hospitalization. Baseline mean (SD) PANSS score was 93(8.2), consistent with acute schizophrenia.
This study will provide important efficacy and safety information on two LAI options available for initiation during a hospitalization for schizophrenia.