Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | RECRUITING | 380 | — | — | Apr 23, 2026 | Dec 1, 2028 | May 28, 2026 | 2 | United States |
| NCT03397134 | Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia | PHASE3 | COMPLETED | 515 | — | — | Dec 15, 2017 | Feb 15, 2021 | Apr 28, 2023 | 39 | United States, Bulgaria +2 |
The Marder Negative Symptoms Factor Score (NSFS) derived from the complete Positive and Negative Syndrome Scale (PANSS) has been the most frequently used scale in schizophrenia clinical studies focusing on negative symptoms. The PANSS measures comprehensive psychiatric symptoms, including positive, negative, and general symptoms. The full PANSS rates the patient on 30 different symptoms from 1 (absent) to 7 (extreme) based on an interview as well as reports of family members or primary care hospital workers. Negative symptoms will be defined by PANSS negative subscore (N1+N2+N3+N4+N5+N6+N7). Higher scores indicate more severe symptoms.
The Marder negative symptoms factor score (NSFS) derived from the complete Positive and Negative Syndrome Scale (PANSS) has been the most frequently used scale in schizophrenia clinical studies focusing on negative symptoms The PANSS measures comprehensive psychiatric symptoms, including positive, negative, and general symptoms. The full PANSS rates the patient on 30 different symptoms from 1 (absent) to 7 (extreme) based on an interview as well as reports of family members or primary care hospital workers. The NSFS consists of the sum of the negative symptom PANSS items N1, N2, N3, N4, N6, G7, and G16 (minimum score = 7; maximum score = 49). Higher scores indicate more severe symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo to Roluperidone | EXPERIMENTAL | Placebo administered as an oral dose daily from Day 1 to Week 12 (Phase A), then Roluperidone 64 mg administered as an oral dose daily from Week 12 +1 day to Week 52 (Phase B). |
| Placebo to Antipsychotic | EXPERIMENTAL | Placebo administered as an oral dose daily from Day 1 to Week 12 (Phase A), then antipsychotic (risperidone 4 mg, aripiprazole 10 mg, or olanzapine 10 mg) administered as an oral dose daily from Week 12 +1 day to Week 52 (Phase B). |
| Roluperidone to Roluperidone | EXPERIMENTAL | Roluperidone 64 mg administered as an oral dose daily from Day 1 to Week 12 (Phase A), then Roluperidone 64 mg administered as an oral dose daily from Week 12 +1 day to Week 52 (Phase B). |
| Roluperidone to Antipsychotic | EXPERIMENTAL | Roluperidone 64 mg administered as an oral dose daily from Day 1 to Week 12 (Phase A), then antipsychotic (risperidone 4 mg, aripiprazole 10 mg, or olanzapine 10 mg) administered as an oral dose daily from Week 12 +1 day to Week 52 (Phase B). |
| Roluperidone 64 mg | EXPERIMENTAL | Roluperidone 64 mg for entire study |
| Roluperidone 32 mg | EXPERIMENTAL | Roluperidone mg for entire study |
| Placebo-1 | PLACEBO_COMPARATOR | Placebo for 12 weeks followed by Roluperidone 64 mg during open-label extension |
| Placebo-2 | PLACEBO_COMPARATOR | Placebo for 12 weeks followed by Roluperidone 32 mg during open-label extension |
| Name | Type | Description |
|---|---|---|
| Roluperidone | DRUG | Roluperidone 64 mg |
| risperidone | DRUG | risperidone 4 mg |
| aripiprazole | DRUG | aripiprazole 10 mg |
| olanzapine | DRUG | olanzapine 10 mg |
| Placebo | DRUG | Placebo |
| Placebo Oral Tablet | DRUG | Placebo administered as a single dose once daily |
| Roluperidone 32 mg | DRUG | Roluperidone administered as a single dose once daily |
| Roluperidone 64 mg | DRUG | Roluperidone administered as a single dose once daily |
Inclusion Criteria: * Subject and subject's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the subject is judged by the investigator as being capable of understanding the study requirements. * Male or female, 18 to 55 year...