Actively Recruiting
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
Led by Minerva Neurosciences · Updated on 2026-05-04
380
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject and legal representative provided informed consent and can understand study requirements
- Male or female aged 18 to 55 years with body mass index </= 35.0 kg/m2 at screening
- Meets DSM-5 criteria for schizophrenia confirmed by full psychiatric interview and MINI
- Has a caregiver or family member who supports compliance and has frequent contact
- Diagnosed with schizophrenia at least 1 year before screening
- Stable positive and negative symptoms for last 6 months as per clinician or caregiver
- Currently outpatient with no hospitalization for acute exacerbation or worsening in last 6 months
- Stable living condition for last 6 months
- No hospitalization within 6 months before screening unless for documented social reasons with approval
- PANSS negative subscale score > 20 at screening and baseline with less than 4 points difference
- Discontinued psychotropic medications by start of washout phase
- No history of violence against self or others
- Females not of childbearing potential or females of childbearing potential with negative pregnancy test using two effective contraception methods
- Normal or ultrarapid CYP2D6 metabolizer with activity score ≥ 1.25 confirmed by genotyping
- Subject and caregiver deemed reliable and cooperative by investigator
You will not qualify if you...
- Current major depressive disorder, bipolar disorder, panic disorder, OCD, intellectual disability, or drug/alcohol addiction
- PANSS item score > 4 on excitement, suspiciousness, hostility, uncooperativeness, or poor impulse control
- Calgary Depression Scale score > 6
- Barnes Akathisia Rating Scale scores indicating akathisia
- Condition due to drugs or general medical conditions
- Serious suicidal behavior within past year
- Substance use disorder within 3 months except caffeine and smoking
- Positive urine drug or alcohol screen except prescription benzodiazepines
- Cannot discontinue psychotropics
- Clozapine use within 6 months except low-dose for insomnia
- Recent electroconvulsive therapy or transcranial magnetic stimulation within 12 months
- Use of long-acting or depot antipsychotics without sufficient washout
- Significant renal disorder or eGFR < 60 mL/min
- Major or unstable neurological, metabolic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder
- History of seizures except single childhood febrile seizure
- Clinically significant lab or physical abnormalities unresolved by baseline
- Low potassium, calcium, or magnesium on pretreatment labs
- Current systemic infection including hepatitis B, C, HIV, or tuberculosis
- Medications that increase QT interval or inhibit CYP2D6
- Significant ECG abnormalities or risk factors for Torsade de Pointes
- History of myocardial infarction or syncope
- Women or men unwilling or unable to use birth control
- Pregnant or lactating women or planning pregnancy
- Participation in recent clinical studies as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CBH Health, LLC dba CenExel
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
2
Hassman Research Institute, LLC dba CenExel
Marlton, New Jersey, United States, 08053
Actively Recruiting
Research Team
C
Chief Operating Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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