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Tests treatment safety and results for Negative Symptoms of Schizophrenia
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
ClinicalTrials.gov ID: NCT07565428
What this study is testing
What is Roluperidone?
Roluperidone is an investigational medicine, being studied as a potential treatment for negative symptoms of schizophrenia.
Also referred to as MIN-101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Subject and subject's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the...
- Male or female, 18 to 55 years of age, inclusive, and body mass index (BMI) \</= 35.0 kg/m2 at Screening.
- Meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5), as...
- Has a caregiver or family member or health care personnel (as permitted by local regulations) who can provide information towards assessment and...
- Documented diagnosis of schizophrenia for at least 1 year before screening into the trial.
You likely can't join if
- Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual...
- PANSS item score of \> 4 on any of the following items: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8...
- A Calgary Depression Scale for Schizophrenia (CDSS) total score \> 6.
- A score of \>/= 2 on any 2 items of items 1, 2, or 3, or a score of \>/= 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).
- Subject's condition is due to direct physiological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition.
- Current or recent history of serious suicidal behavior within the past 1 year.
See the full eligibility criteria
Who can join
- 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...
- Male or female, 18 to 55 years of age, inclusive, and body mass index (BMI) \</= 35.0 kg/m2 at Screening.
- Meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5), as established by a full psychiatric interview in conjunction with the Mini...
- Has a caregiver or family member or health care personnel (as permitted by local regulations) who can provide information towards assessment and support the subject in terms of compliance with the protocol. The...
- Documented diagnosis of schizophrenia for at least 1 year before screening into the trial.
- Is stable in terms of both positive and negative symptoms of schizophrenia over the last 6 months according to his or her clinician and/or based on documentation in the clinical chart or medical records, and/or based on...
- Is currently an outpatient and has not been hospitalized for the last 6 months for acute exacerbation or symptoms worsening.
- Has had a stable living condition (residence) for the last 6 months.
- Has not been hospitalized within 6 months before Screening. A subject hospitalized for any time period during the last 6 months for social reasons or currently hospitalized for reasons not related to their schizophrenia...
- Has a score of \> 20 on the PANSS negative subscale score ([sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND \< 4 points absolute difference between Visits 1 and 3.
- Must discontinue any psychotropic medications by or at the beginning of the washout phase (Day -2). The rate of washout/discontinuation of psychotropic medications during the Screening period should be gradual in order...
- Has no history of violence against self or others.
- Female subject, if not of childbearing potential, defined as a woman who is post-menopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
- Female subject, if of childbearing potential, must test negative for pregnancy and must use 2 approved methods of highly effective contraception.
- Must be normal or ultrarapid metabolizer for cytochrome P450 (CYP) 2D6, defined as having an activity score (AS) of \>/= 1.25 as determined by study-specific genotyping test before the first dose of study drug dose is...
- Subject and the caregiver are considered by the investigator to be reliable and likely to cooperate with the assessment procedures.
What rules you out
- Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14), drugs or alcohol addiction.
- PANSS item score of \> 4 on any of the following items: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
- A Calgary Depression Scale for Schizophrenia (CDSS) total score \> 6.
- A score of \>/= 2 on any 2 items of items 1, 2, or 3, or a score of \>/= 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).
- Subject's condition is due to direct physiological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition.
- Current or recent history of serious suicidal behavior within the past 1 year.
- History of substance use disorder within 3 months of the Screening visit (excluding caffeine and cigarette smoking).
- Positive urine drug screen for any drug of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription...
- Cannot be discontinued from psychotropics.
- Received clozapine within 6 months of the Screening visit except when used for insomnia at doses \</= 100 mg per day.
- Was treated with electroconvulsive therapy or transcranial magnetic stimulation in the last 12 months.
- Is receiving treatment with long-acting or depot antipsychotic medication unless the drug has been discontinued for a full cycle drug (1 months, 3 months, 6 months depending on the drug formulation) to allow for...
- History of significant renal disorder, including an eGFR \< 60 mL/min at the Screening visit.
- History of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, hematological, pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder.
- History of seizures (people with a history of a single childhood febrile seizure may be enrolled in this study).
- Clinically significant abnormalities in hematology, blood chemistry (including ALT or AST \> 3 × the upper limit of normal [ULN], total bilirubin \> 2 × ULN, or alkaline phosphatase \> 1.5 × ULN), or physical...
- Safety laboratory results from the Pretreatment Phase show one or more of the following: potassium \< 3.4 mmol/L, calcium \< 2.07 mmol/L, or magnesium \< 0.70 mmol/L.
- Current systemic infection (e.g., Hepatitis B, Hepatitis C, human immunodeficiency virus [HIV], tuberculosis). A subject with positive Hepatitis B core antibody test and negative Hepatitis B Surface Antigen (HBsAg) may...
- Requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).
- Requires medication inhibiting CYP2D6.
- Clinically significant ECG abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia's formula (QTcF) \> 430 msec for males and \> 450 msec for...
- Familial or personal history of long QT syndrome or with another risk factor for Torsade de Pointes.
- History of myocardial infarction based on medical history or ECG findings at Screening.
- Syncope.
- Woman of child-bearing potential, or man, who is unwilling or unable to use accepted methods of birth control.
- Woman with a positive pregnancy test, is lactating, or is planning to become pregnant during the study.
- Participated in another clinical study that was completed within 6 months prior to Screening or has previously participated in \> 2 clinical studies with experimental medication within the past 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Culver City, California, United States
- Tampa, Florida, United States
- Gaithersburg, Maryland, United States
- Marlton, New Jersey, United States
- Richardson, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Culver City, California, United States; Tampa, Florida, United States; Gaithersburg, Maryland, United States; Marlton, New Jersey, United States; Richardson, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.