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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
Roluperidone 64 mg
risperidone 4 mg
aripiprazole 10 mg
olanzapine 10 mg
Placebo
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States
RECRUITINGProScience Research Group
Culver City, California, United States
RECRUITINGCollaborative Neuroscience Research, LLC
Garden Grove, California, United States
RECRUITINGClinical Innovations, Inc. dba CITrials
Riverside, California, United States
RECRUITINGVelocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
RECRUITINGBehavioral Clinical Research, Inc.
Hollywood, Florida, United States
RECRUITINGForCare Clinical Research
Tampa, Florida, United States
RECRUITINGAtlanta Center for Medical Research, LLC
Atlanta, Georgia, United States
RECRUITINGCenExel iResearch, LLC
Decatur, Georgia, United States
RECRUITINGCBH Health, LLC dba CenExel
Gaithersburg, Maryland, United States
RECRUITING...and 3 more locations
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.
Time frame: Phase A: Screening, Baseline, Weeks 2, 4, 8, 12
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.
Time frame: Phase A: Baseline and Weeks 4, 8, 12
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.
Time frame: Phase A: Screening, Baseline, and Weeks 2, 4, 8, 12
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