Status:
COMPLETED
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
Lead Sponsor:
Minerva Neurosciences
Conditions:
Negative Symptoms in Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of the Co-Administration of Roluperidone and Olanzapine in Adult Subjects with Moderate ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06107803
Start Date
October 13 2023
End Date
January 12 2024
Last Update
March 26 2025
Active Locations (3)
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1
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States, 92845
2
CBH Health, LLC
Gaithersburg, Maryland, United States, 20877
3
Hassman Research Institute
Marlton, New Jersey, United States, 08053