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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.
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights


This trial looks at the safety and tolerability of a drug called OLZ/SAM in children with schizophrenia or bipolar I disorder.

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.Check my eligibility
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.See study design
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:
I am not on medications that can't be taken with olanzapine.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events

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)
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

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.

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,652 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
~125 spots leftby Sep 2027