A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Minerva Neurosciences
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provided informed consent
Body mass index (BMI) \< 35 kg/m2
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)
Documented diagnosis of schizophrenia for at least 1 year before screening
Stable in terms of both positive and negative symptoms of schizophrenia over the last 3 months
Score of \> 20 on the PANSS original negative symptoms subscale (Sum of N1+N2+N3+N4+N5+N6+N7) at Screening and Baseline (Day -1) AND \< 4 points absolute difference between the 2 visits
Discontinued psychotropic medications without risk to their clinical status or safety by Baseline
Female subject, if not of childbearing potential, must be a woman who is post-menopausal or permanently sterilized
Female subject, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method
Must be normal metabolizer for P450 CYP 2D6, defined as a subject that has at least one functional allele (eg, \*1, \*2 or \*35), as determined by study-specific genotyping test before the first drug dose is administered
Has a caregiver or family member or health care personnel who can provide information towards assessment and support the subject in terms of compliance with the protocol
You may not be if
Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14)
PANSS item score of \> 4 on:
* P4 Excitement/Hyperactivity
* P6 Suspiciousness/persecution
* P7 Hostility
* G8 Uncooperativeness
* G14 Poor impulse control
CDSS total score \> 6
Score of ≥ 2 on any 2 of items 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes Akathisia Rating Scale (BARS)
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
Positive urine drug screen for drugs of abuse
Currently taking proton pump inhibitors (PPI)
Current systemic infection (eg, Hepatitis B, Hepatitis C, human immunodeficiency virus \[HIV\], tuberculosis)
Requires or may require concomitant treatment with any other medication likely to increase QT interval
Requires medication inhibiting CYP2D6
Safety laboratory results show one or more of the following: potassium \<3.4 mmol/L, or calcium \<2.07 mmol/L, or magnesium \<0.70 mmol/L
Clareo Health | A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
