What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as second-generation antipsychotics like olanzapine, often cause side effects including weight gain, metabolic syndrome, and extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism. Olanzapine is particularly associated with significant weight gain and metabolic issues. Samidorphan, an opioid receptor antagonist, is used in combination with olanzapine (OLZ/SAM) to mitigate the weight gain associated with olanzapine. Other side effects of second-generation antipsychotics can include sedation, somnolence, and, less frequently, cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of schizophrenia, including olanzapine, which alters dopamine and serotonin activity to manage symptoms. Olanzapine is often associated with metabolic side effects, including weight gain. To address this, OLZ/SAM combines olanzapine with samidorphan, an opioid receptor antagonist, to mitigate weight gain. Other second-generation antipsychotics approved for schizophrenia include risperidone, quetiapine, and aripiprazole, which also target dopamine and serotonin receptors but vary in their side effect profiles and efficacy.

What other types of research exist?

LY2140023, a metabotropic glutamate receptor 2/3 (mGlu2/3) agonist, is a promising novel alternative for schizophrenia treatment, showing significant improvements in symptoms and good safety and tolerability in clinical trials.

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Atypical Antipsychotic

OLZ/SAM for Schizophrenia

Phase 3

Waitlist Available

Research Sponsored by Alkermes, Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial evaluates the safety and tolerability of OLZ/SAM in children and adolescents with schizophrenia or Bipolar I disorder. OLZ/SAM combines olanzapine to manage symptoms and samidorphan to reduce weight gain. Olanzapine is a well-established antipsychotic effective for schizophrenia and bipolar I disorder, but its use is limited by significant weight gain; samidorphan is added to mitigate this side effect.

Who is the study for?

This trial is for kids with schizophrenia or Bipolar I disorder who finished a previous study (ALKS 3831-A311/A312) or left it due to weight gain. They mustn't be at risk of harm, have family support, agree to follow birth control rules, and can benefit from continued OLZ/SAM treatment.

What is being tested?

The trial tests the long-term safety of a medication combo called OLZ/SAM in young patients. It's an extension study for those who've been part of prior research on this treatment and aims to see how they do over more time.

What are the potential side effects?

While not specified here, common side effects of medications like OLZ/SAM may include drowsiness, weight gain, dry mouth, restlessness, and changes in metabolism. Each child's experience with side effects could vary.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not on medications that can't be taken with olanzapine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: All subjectsExperimental Treatment1 Intervention

All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OLZ/SAM

2021

Completed Phase 1

~10

0 / 1Eligibility criteria met

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 olanzapine, work by altering dopamine and serotonin activity to reduce symptoms like hallucinations and delusions. Olanzapine is often combined with samidorphan, an opioid receptor antagonist, to mitigate weight gain, a common side effect. This combination is crucial as it helps manage the symptoms effectively while minimizing adverse metabolic effects, thereby improving treatment adherence and the overall quality of life for patients.

New discoveries for an old drug: a review of recent olanzapine research.Pharmacologic treatment of schizophrenia: what the future holds.

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Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor

115 Previous Clinical Trials

26,744 Total Patients Enrolled

22 Trials studying Schizophrenia

5,862 Patients Enrolled for Schizophrenia

David McDonnell, MDStudy DirectorAlkermes, Inc.

6 Previous Clinical Trials

1,032 Total Patients Enrolled

4 Trials studying Schizophrenia

965 Patients Enrolled for Schizophrenia

Media Library

OLZ/SAM (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04987229 — Phase 3

Schizophrenia Research Study Groups: All subjects

Schizophrenia Clinical Trial 2023: OLZ/SAM Highlights & Side Effects. Trial Name: NCT04987229 — Phase 3

OLZ/SAM (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987229 — Phase 3

~118 spots leftby Sep 2027

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