Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
Public ClinicalTrials.gov record NCT07565428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 52-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Evaluate the efficacy, as well as safety and pharmacokinetics, of Roluperidone in improving the negative symptoms of schizophrenia in adult subjects in Phase A of study, followed by Phase B of study to evaluate the relapse rate of Roluperidone and antipsychotic medications.
Study identification
- NCT ID
- NCT07565428
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 380 participants
Conditions and interventions
Conditions
Interventions
- Roluperidone Drug
- risperidone Drug
- aripiprazole Drug
- olanzapine Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 22, 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2028
- Last update posted
- Jul 27, 2026
2026 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Innovations, Inc. dba CITrials | Bellflower | California | 90706 | Recruiting |
| ProScience Research Group | Culver City | California | 90230 | Recruiting |
| Collaborative Neuroscience Research, LLC | Garden Grove | California | 92845 | Recruiting |
| Clinical Innovations, Inc. dba CITrials | Riverside | California | 92506 | Recruiting |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | Recruiting |
| Behavioral Clinical Research, Inc. | Hollywood | Florida | 33021 | Recruiting |
| ForCare Clinical Research | Tampa | Florida | 33613 | Recruiting |
| Atlanta Center for Medical Research, LLC | Atlanta | Georgia | 30331 | Recruiting |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | Recruiting |
| CBH Health, LLC dba CenExel | Gaithersburg | Maryland | 20877 | Recruiting |
| Hassman Research Institute, LLC dba CenExel | Marlton | New Jersey | 08053 | Recruiting |
| New York State Psychiatric Institute | New York | New York | 10032 | Recruiting |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07565428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07565428 live on ClinicalTrials.gov.