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Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03397134
Recruitment Status : Active, not recruiting
First Posted : January 11, 2018
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Minerva Neurosciences

Brief Summary:
MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.

Condition or disease Intervention/treatment Phase
Negative Symptoms of Schizophrenia Drug: Placebo Oral Tablet Drug: Roluperidone 32 mg Drug: Roluperidone 64 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : May 26, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Roluperidone 64 mg
Roluperidone 64 mg for entire study
Drug: Roluperidone 64 mg
Roluperidone administered as a single dose once daily

Experimental: Roluperidone 32 mg
Roluperidone mg for entire study
Drug: Roluperidone 32 mg
Roluperidone administered as a single dose once daily

Placebo Comparator: Placebo-1
Placebo for 12 weeks followed by Roluperidone 64 mg during open-label extension
Drug: Placebo Oral Tablet
Placebo administered as a single dose once daily

Drug: Roluperidone 64 mg
Roluperidone administered as a single dose once daily

Placebo Comparator: Placebo-2
Placebo for 12 weeks followed by Roluperidone 32 mg during open-label extension
Drug: Placebo Oral Tablet
Placebo administered as a single dose once daily

Drug: Roluperidone 32 mg
Roluperidone administered as a single dose once daily

Primary Outcome Measures :
  1. Change from Baseline to Week 12 in Marder negative symptoms factor score (NSFS) [ Time Frame: Change from Baseline to Week 12 ]
    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.

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in Personal and Social Performance (PSP) [ Time Frame: Change from Baseline to Week 12 ]
    The Personal and Social Performance (PSP) scale is used to evaluate the effect of treatment with antipsychotic drugs on functional performance.The PSP considers 4 areas of social and individual performance (socially useful activities, including work and study; personal and social relationships; self-care; disturbing and aggressive behaviors). The clinician must assign an initial six-degree of severity to each area (absent, mild, manifest, marked, severe or very severe). Then, in a table with levels of score set the correspondent decimal (e.g., 21-30), according to the observed performance and, within the decimal range, the assigned unit to determine the final score (e.g., within the range 21-30, the performance corresponds to the score 24). The resulting final value is a single measurement from zero to 100% of functioning.

  2. Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Change from Baseline to Week 12 ]
    The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients

  3. Safety assessments [ Time Frame: Screening through Week 12 and open-label phase Week 13 through 54 ]
    Adverse events, laboratory values, ECG, vital signs, physical exam, Abnormal involuntary movement scale, Barnes Akathisia Scale, Simpson-Angus Scale, and Sheehan Suicidality Tracking Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient and patient's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the patient is judged by the investigator as being capable of understanding the study requirements.
  • Male or female patient, 18 to 55 years of age, inclusive, and body mass index (BMI) < 35 kg/m(2) at Screening.
  • Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview.
  • Has a reliable caregiver or family member or health care personnel who can provide information towards assessment and support the patient in terms of compliance with the protocol. The caregiver must have contacts with the patient daily for at least 1 hour each time and is not expected to change during the trial.
  • Documented diagnosis of schizophrenia for at least 1 year before screening into the trial.
  • Patient is stable in terms of positive and negative symptoms of schizophrenia over the last 6 months according to his or her treating psychiatrist and based on documentation in the clinical chart.
  • Patient is currently an outpatient and has not been hospitalized for the last 6 months for acute exacerbation or symptoms worsening. Patients hospitalized during the last 6 months for social reasons or are currently hospitalized for social reasons can be included only with Sponsor's Responsible Medical Officer's approval, and the social reasons must be documented in the electronic case report form (eCRF).
  • Patient with a score of > 20 on the PANSS negative subscore (the original PANSS scale [ Sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND < 4 points absolute difference between 2 visits.
  • Patients can be on any psychotropic before the trial if the psychotropics can be discontinued at the beginning of the washout phase without risking the patient's clinical status or safety.
  • No history of violence against self or others during the last 1 year.
  • Female patient who are not of childbearing potential, defined as women who are postmenopausal (defined as spontaneous amenorrhoea for at least 1 year or spontaneous amenorrhoea for at least 6 months confirmed by follicle stimulating hormone result of ≥ 40 IU/mL) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
  • Female patient, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method.
  • Patient must be extensive metabolizers for cytochrome P450 (CYP2D6), defined as a subject that has at least one functional allel (e.g., *1 or *2), as determined by study-specific genotyping test before the first drug dose is administered.
  • Patient and the caregiver are considered by the investigator to be reliable and likely to cooperate with the assessment procedures.

Exclusion Criteria:

  • Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14).
  • Patient with PANSS item score of > 4 on: 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 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).
  • Patient's condition is due to direct psychological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition.
  • Has a current or recent history of serious suicidal behavior within the past 1 year.
  • Patient has a history of substance use disorder within 3 months of the Screening visit (excluding caffeine and cigarette smoking).
  • Positive urine drug screen for drugs of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription benzodiazepines).
  • Patient who cannot be discontinued from psychotropics other than those allowed.
  • Patient who received clozapine within 6 months of the Screening visit.
  • Patient receiving treatment with long-acting or depot antipsychotic medication unless his/her next scheduled dose will occur during the protocol Screening period and can be omitted to allow for sufficient washout before receiving the study drug.
  • Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
  • Patient with a history of seizures (patient with a history of a single childhood febrile seizure may be enrolled in this study).
  • Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 6 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study.
  • Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation.
  • Current systemic infection (e.g., Hepatitis B, Hepatitis C, human immunodeficiency virus [HIV], tuberculosis). Patients with positive Hepatitis B core antibody test and negative Hepatitis B surface Antigen (HBsAg) may be included in the study if aminotransferase levels (alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) [ALT/SGPT] and aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) [AST/SGOT] do not exceed 2 times upper limit of normal (ULN).
  • Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).
  • Patient who requires medication inhibiting CYP 2D6 or CYP 3A4.
  • Patient with a 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 females.
  • Patient with a history of myocardial infarction based on medical history or ECG findings at Screening.
  • Familial or personal history of long QT syndrome or with additional risk factors for Torsade de Pointes.
  • Subjects whose safety laboratory results show hypokalemia, hypomagnesemia, hypocalcemia.
  • Patients with unexplained syncope.
  • Woman of child-bearing potential, or man, who are 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.
  • Patient who participated in another clinical study within 3 months prior to Screening, or received roluperidone previously, or has previously participated in > 2 clinical studies with experimental medication (previous participation in 3 clinical studies with experimental medication will require approval of the sponsor before eligibility is determined).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03397134

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Sponsors and Collaborators
Minerva Neurosciences
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Responsible Party: Minerva Neurosciences Identifier: NCT03397134    
Other Study ID Numbers: MIN-101C07
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders