NCT06107803CompletedPhase 1
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
A Phase 1b, In-Patient Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of the Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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 to Severe Negative Symptoms of Schizophrenia. The main question this clinical trial aims to answer are the pharmacodynamic and pharmacokinetic effects and safety of the concomitant therapy of Roluperidone with an established and widely used antipsychotic, such as olanzapine in order to provide further guidance to clinical practitioners that may prescribe off-label use of these drugs concomitantly in clinical practice. Eligible Participants will undergo the following study phases in the clinic: * Screening Phase: Between 2 and up to 28 days during which study eligibility will be established and subjects receiving psychotropics will be washed out. Subjects will remain inpatient at the clinical site at least through the end of Treatment Phase 2. * Treatment Phase 1: After the Baseline Visit, Roluperidone 64 mg/day will be administered as a monotherapy for 7 days (Days 1-7). * Treatment Phase 2: Concomitant administration of Olanzapine 10 mg/day and Roluperidone 64 mg/day for 10 days, starting on Day 8 (Days 8-17). Subjects may be discharged from the clinic at least 48 hours after the last administration of the study drugs and after the collection of the last plasma sample; however, the inpatient period may be extended at the discretion of the investigator. End of Study (EOS): Will take place at least 14 days after the last dose of the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 13 Oct 2023
- Start date
- 13 Oct 2023
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Minerva Neurosciences
- Diseases
- Schizophrenia
- NCT number
- NCT06107803
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 13 Oct 2023 to the primary completion date, 12 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Requires medication inhibiting CYP2D6
Other illness
- Current systemic infection (eg, Hepatitis B, Hepatitis C, human immunodeficiency virus \[HIV\], tuberculosis)
Lab values
- Requires or may require concomitant treatment with any other medication likely to increase QT interval
- 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
Age
- Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CBH Health, LLC Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Collaborative NeuroScience Research , LLC Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Hassman Research Institute Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.