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Roluperidone + Olanzapine for Schizophrenia

Phase 1

Waitlist Available

Research Sponsored by Minerva Neurosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, baseline, days 1, 7, 8, and 17, and day 31

Awards & highlights

Study Summary

This trial will evaluate safety, effects, and side effects of combining Roluperidone with Olanzapine for treating schizophrenia in adults.

Who is the study for?

Adults with schizophrenia for at least a year, BMI under 35, stable symptoms, and not on conflicting meds can join. They must have moderate to severe negative symptoms but no major depressive or bipolar disorder. Women of childbearing potential need double contraception.Check my eligibility

What is being tested?

The trial tests Roluperidone alone for a week then combined with Olanzapine for another ten days in adults with schizophrenia. It aims to understand the safety and how these drugs work together when taken by patients.See study design

What are the potential side effects?

Potential side effects may include typical antipsychotic reactions like drowsiness, weight gain, dry mouth, restlessness (akathisia), increased blood sugar or cholesterol levels. Specific side effects from combining these drugs are being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, baseline, days 1, 7, 8, and 17, and day 31

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, baseline, days 1, 7, 8, and 17, and day 31

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, days 1, 7, 8, and 17, and day 31 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abnormal Involuntary Movement Scale (AIMS)

Adverse events

Barnes Akathisia Rating Scale (BARS)

+10 more

Other outcome measures

Calgary Depression Scale for Schizophrenia (CDSS)

Clinical Global Impression - Severity Rating (CGI-S)

Positive and Negative Symptoms Scale (PANSS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Phase 2Experimental Treatment2 Interventions

Roluperidone 64 mg oral and olanzapine 10 mg oral administered at the same time daily for 10 days on Days 8-17.

Group II: Treatment Phase 1Experimental Treatment1 Intervention

Roluperidone 64 mg monotherapy administered as an oral dose daily for 7 days on Days 1-7.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Roluperidone 64 mg

2017

Completed Phase 3

~540

Olanzapine 10 MG

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Minerva NeurosciencesLead Sponsor

5 Previous Clinical Trials

944 Total Patients Enrolled

2 Trials studying Schizophrenia

547 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study accept persons aged under 80 years for participation?

"The age range for this clinical trial is 18-55; any applicants younger or older than that will be excluded from the study."

Answered by AI

To what extent can individuals participate in this research?

"Eligible individuals for this experiment must have schizophrenia and be between 18 to 55 years of age. This clinical trial is searching for a total of 18 participants."

Answered by AI

How many individuals have volunteered for enrolment in this experiment?

"This clinical trial necessitates 18 participants, who satisfy the necessary requirements for inclusion. The subjects can participate out of CBH Health in Gaithersburg or Hassman Research Institute in Marlton - both are located within the United States."

Answered by AI

Is the initial stage of this treatment regimen officially accepted by the FDA?

"As this is an early-phase trial, the safety of Treatment Phase 1 was evaluated as a low score of one due to limited evidence in terms of efficacy and precaution."

Answered by AI

Are volunteers still being accepted for this experiment?

"Affirmative. The clinical trial registration on clinicaltrials.gov shows that the study is currently recruiting patients, commencing October 13th 2023 and last updated October 24th 2023. This medical research requires 18 particpants to be recruited from 3 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107803.