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.
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 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 International Neuropsychiatric Interview (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 caregiver must have contact with the subject frequently and is not expected to change during the trial.
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).
Parallel
Roluperidone
DrugRoluperidone 64 mg
risperidone
Drugrisperidone 4 mg
aripiprazole
Drugaripiprazole 10 mg
olanzapine
Drugolanzapine 10 mg
Placebo
DrugPlacebo
Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS)
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.
Change from Baseline to Week 12 in the Personal and Social Performance (PSP) Total Score
PSP scale=validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work \& study), personal \& social relationships, self-care, \& disturbing and aggressive behaviors. PSP is 100-item scale, divided in 10 similar intervals. Score based on first assessing patient's performance in 4 domains by assigning initial degree of severity (absent, mild, manifest, marked, severe, or very severe) to each domain. Second, a table with levels of score is used, setting correspondent decile (eg, 21-30), according to observed performance across the 4 domains. Third, within selected decile, final value is assigned (eg, within range 21-30, the performance corresponds to score 24). Resulting final value is single measurement from 0-100% of functioning. This single value is PSP total score. Lower scores 1-30=poor functioning; scores 31-60=varying degrees of disability; and scores 71-100=disability absence or only mild difficulties.
Change from Baseline to Week 12 in Clinical Global Impression - Severity (CGI-S) Scale
The CGI-S is a clinician-rated scale that is designed to rate the severity of the patient's illness at the time of assessment, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function relative to the clinician's past experience with patients who have the same diagnosis and improvement with treatment. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating, according to: normal (not at all ill) = 1; borderline mentally ill = 2; mildly ill = 3; moderately ill = 4; markedly ill = 5; severely ill = 6; or extremely ill = 7.
Safety Assessments
Adverse Event assessment throughout the study from the time of informed consent form signature to End of Study.
Number of Subjects who Relapse over 12 Weeks of Double-blind Treatment (Phase A) and over 52 Weeks of Treatment (Phase B)
The number and percentage of subjects who relapse in the roluperidone group versus the placebo group over 12 weeks of double-blind treatment in Phase A of the study and over 52 weeks of treatment in Phase B of the study will be summarized.
Click on the lead sponsor to view all of their trials.
