A Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.

Aripiprazole is an atypical antipsychotic for the maintenance treatment of acute and chronic schizophrenia and bipolar 1 disorder in adults. This was a phase II, proof-of-concept, national, multicenter, randomized, double-blind clinical trial to compare the efficacy and safety of WAS123 in the maintenance treatment of patients with schizophrenia, with a parallel design between 2 groups and controlled by an active comparator (Aripiprazole). Primary Objective: To evaluate the non-inferiority in efficacy of the WAS123 compared to the dosage of Aripiprazole in the overall symptomatic control of participants with schizophrenia. Methodology: A total of 121 participants were randomized, and assigned to 1 of the 2 treatment arms of the trial in a 1:1 ratio. This was a double-blind trial, no participant or person involved in its conduct, including those people responsible for data management, were aware of the allocation of treatments to participants. Diagnosis and Main Criteria for Inclusion and Exclusion: The trial target population was made up of adults of both sexes aged 18 or over and 65 or under diagnosed with schizophrenia according to the DSM-5 diagnostic criteria. Participants were ineligible if they had another psychiatric disorder with psychotic symptoms other than schizophrenia or with schizophrenia refractory or resistant to antipsychotic treatment. Duration of Treatment: The treatment period for the trial consisted of a mandatory 8-week (56-day) run-in for symptom stabilization, followed by randomization and 12 weeks (90 days) of treatment with the trial medications , totaling 20 weeks. Statistical Methods: The primary endpoint was analyzed using a generalized linear model including treatment effect and baseline as covariate and parameters were estimated by maximum likelihood. The treatment effect was expressed as the difference between the trial medication and the comparator, and a 95% confidence interval (CI) for this difference was calculated. Non-inferiority was concluded if the upper limit of the 95% CI was less than the pre-specified non-inferiority margin. As a sensitivity analysis, the same model was applied to data from the mITT set. AEs, diseases, and comorbidities were coded using MedDRA. Safety analyses were descriptive and summarized vital signs, clinical, laboratory, and physical examination findings, as well as all AEs. AE frequencies were presented by treatment group according to causality, intensity, frequency, and severity.