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

Conditions

• Negative Symptoms of Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Roluperidone — DRUG
  Roluperidone 64 mg
• risperidone — DRUG
  risperidone 4 mg
• aripiprazole — DRUG
  aripiprazole 10 mg
• olanzapine — DRUG
  olanzapine 10 mg
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

First listed

May 4, 2026

Start date

Apr 23, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo to Roluperidone
  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 64 (Phase B).
• Experimental: Placebo to Antipsychotic
  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 64 (Phase B).
• Experimental: Roluperidone to Roluperidone
  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 64 (Phase B).
• Experimental: Roluperidone to Antipsychotic
  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 64 (Phase B).

Primary Outcome Measure

Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS) [ Time Frame: Phase A: Screening, Baseline, Weeks 2, 4, 8, 12 ]

Central Contacts

• Chief Operating Officer
  617-600-7373
  [email protected]

Locations (13)

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