clinical 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
Minerva Neurosciences·phase3·recruiting·n = 380
Negative Symptoms of SchizophreniaRoluperidonerisperidonearipiprazoleolanzapinePlacebo
brief 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.
started
Apr 1, 2026
primary completion
Dec 1, 2027
completion
Dec 1, 2028
last updated
May 4, 2026
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 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol