drugset / Trial / NCT07565428
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
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2026-04-23
- Primary completion
- 2027-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 10 mg | — |
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Subject | Risperidone | Other / unclassified | 4 mg | — |
| Subject | Roluperidone | Small molecule | 64 mg | Oral |
Indications
No indication recorded.