Schizophenia DisorderPhase 2REORDERNCT07843056
A Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.
A Phase 2 study testing WAS123 and Aripiprazole (Fixed dose) in people with Schizophenia Disorder, run by EMS at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder
- What is being tested?
- WAS123 and Aripiprazole (Fixed dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2022to 23 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Proof-of-concept, National, Multicenter, Randomized, Double-blind Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.
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.
Read the detailed description
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.
- Conditions
- Schizophenia Disorder
- Being tested
- WAS123, Aripiprazole (Fixed dose)
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAS123Drug
oral dose
Aripiprazole (Fixed dose)Drug
oral daily dose
| Study group | Role | What they receive |
|---|---|---|
| WAS123 | Experimental | oral dose Receives: Drug: WAS123 |
| Aripiprazole | Active comparator | oral daily dose Receives: Drug: Aripiprazole (Fixed dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start10 May 2022
- Primary completion20 Jan 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Cassiano Berto, Study director, Grupo EMS S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843056
- Sponsor's protocol ID
- PNC0421
- Acronym
- REORDER
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that support the reported results may be made available upon reasonable request and subject to Sponsor review and approval, after publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Proof-of-concept, National, Multicenter, Randomized, Double-blind Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT07843056
- Acronym / sponsor ID
- REORDER / PNC0421
- Conditions
- Schizophenia Disorder
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 10 May 2022 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WAS123 | Experimental | Drug: WAS123oral dose |
| Aripiprazole | Active comparator | Drug: Aripiprazole (Fixed dose)oral daily dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAS123oral dose | Drug | WAS123 |
| Aripiprazole (Fixed dose)oral daily dose | Drug | Aripiprazole |
Primary outcome
Score PANSS
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that support the reported results may be made available upon reasonable request and subject to Sponsor review and approval, after publication of the primary study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassiano Berto study director
Grupo EMS S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WAS123 and Aripiprazole (Fixed dose) in people with Schizophenia Disorder, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score PANSS (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.