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

NCT07843056 | Completed Phase 2 DMC

• 1 other identifier: PNC0421
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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). A total of 121 participants were randomized and assigned to either 1 of 2 treatment groups in a 1:1 ratio.

Conditions

Schizophenia Disorder

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Score PANSS

  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.

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

WAS123

EXPERIMENTAL

oral dose

Drug: WAS123

Aripiprazole

ACTIVE COMPARATOR

oral daily dose

Drug: Aripiprazole (Fixed dose)

Interventions

WAS123 DRUG

oral dose

WAS123

Aripiprazole (Fixed dose) DRUG

oral daily dose

Aripiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 to 65 years with the ability to confirm voluntary participation and who agreed to all trial purposes by signing and dating the ICF in duplicate.
• Diagnosis of schizophrenia according to DSM-5 diagnostic criteria and who:
• At Screening:
• Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment, or
• Had an inadequate response to another antipsychotic; or
• Had tolerance issues (e.g., extrapyramidal symptoms, metabolic problems) with the current antipsychotic; or
• Were treatment-naive
• At randomization:
• Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment.
• Participants who met all of the following criteria were considered stable:
• Not hospitalized;
• Total Positive and Negative Syndrome Scale (PANSS) score ≤80;
• Score ≤4 on individual PANSS items (P1, P2, P3, and P6);
• CGI-S score ≤4 (moderately ill);
• CGI-SS score ≤2 (mildly suicidal)

You may not qualify if:

• Any clinical or laboratory findings that were interpreted by the principal investigator as a risk to the participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
• Participants with schizophrenia refractory or resistant to antipsychotic treatment (therapeutic failure with 2 different antipsychotics, after treatment for at least 4 weeks at the maximum tolerated dose);
• Participants who had not responded adequately to previous aripiprazole trials;
• Participants who had used depot antipsychotics or undergone electroconvulsive therapy in the last 3 months;
• History of organic mental disorders, moderate to severe intellectual disability, or another psychiatric disorder with psychotic symptoms other than schizophrenia;
• History of epilepsy, neuroleptic malignant syndrome, clinically relevant tardive dyskinesia, or other medical condition that would expose the participant to undue risk or interfere with trial assessments;
• Diagnosis of substance dependence, including alcohol and benzodiazepines, but excluding nicotine and caffeine;
• Participants with previous cardiac events, such as tachycardia or bradyarrhythmias, or any significant prolongation of the QT interval on the electrocardiogram (ECG);
• Participants who were pregnant, breastfeeding, or planning to become pregnant, or female participants of childbearing potential who were not using a reliable method of contraception;
• Participants with known allergy or hypersensitivity to the components of the medications used during the clinical trial;
• Research participant who participated in clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator considered that there could be direct benefit to them.

Sponsors & Collaborators

• EMS: lead
• Worldwide Clinical Trials: collaborator

Study Sites (1)

Clinica Viver

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cassiano Berto

  Grupo EMS S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: May 10, 2022
• Primary Completion: January 20, 2026
• Study Completion: March 23, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)