What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly serotonin and dopamine receptor antagonists like Roluperidone and Olanzapine, are associated with several side effects. These include metabolic issues such as weight gain, hyperglycemia, and an increased risk of diabetes. Cardiovascular side effects like elevated cholesterol and hypertension are also common. Neurologically, patients may experience extrapyramidal symptoms, sedation, and cognitive dulling. Anticholinergic effects such as dry mouth, constipation, and blurred vision are also frequently reported.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, particularly those that act as Serotonin and Dopamine Receptor Antagonists. Olanzapine, a widely used atypical antipsychotic, was approved by the FDA in 1996. Other similar drugs include Risperidone, approved in 1993, and Quetiapine, approved in 1997. These medications work by antagonizing serotonin and dopamine receptors, which helps in managing the symptoms of schizophrenia. Aripiprazole, another atypical antipsychotic with partial agonist activity at dopamine receptors, was approved in 2002. These drugs are commonly used due to their efficacy in treating both positive and negative symptoms of schizophrenia.

What other types of research exist?

Promising novel alternatives to Roluperidone and Olanzapine for schizophrenia treatment in 2024 include drugs currently in Phase III clinical trials or recently approved. These include Lumateperone, which targets serotonin, dopamine, and glutamate receptors, and KarXT, which combines xanomeline (a muscarinic receptor agonist) with trospium to reduce side effects. Both drugs offer novel mechanisms of action and have shown efficacy in clinical trials.

← Back to Search

Other

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

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of using two medications, Roluperidone and Olanzapine, together in adults with severe schizophrenia symptoms. The goal is to see if this combination can better improve mood and behavior by affecting brain chemicals.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abnormal Involuntary Movement Scale (AIMS)

Adverse events

Barnes Akathisia Rating Scale (BARS)

+10 more

Other study objectives

Calgary Depression Scale for Schizophrenia (CDSS)

Clinical Global Impression - Severity Rating (CGI-S)

Positive and Negative Symptoms Scale (PANSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia, such as Roluperidone and Olanzapine, work by antagonizing dopamine D2 and serotonin 5-HT2A receptors. This dual action helps reduce positive symptoms like hallucinations and delusions by modulating dopamine activity, while also addressing negative symptoms and cognitive deficits through serotonin receptor antagonism. Understanding these mechanisms is important for patients as it explains how these medications can improve their symptoms and informs them about potential side effects, aiding in better management of their condition.

Brexpiprazole and cariprazine: distinguishing two new atypical antipsychotics from the original dopamine stabilizer aripiprazole.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.Schizophrenia - advances in drug therapy.