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Atypical Antipsychotic

OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder

Phase 3
Recruiting
Research Sponsored by Alkermes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to DSM-5 criteria
Be younger than 18 years old
Must not have
Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
Subject presents with a major depressive episode or other neuropsychiatric diagnosis according to DSM-5 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial compares the changes in body mass index (BMI) Z-score of patients following treatment with olanzapine/samidorphan versus olanzapine.

Who is the study for?
This trial is for young people aged 10-17 with bipolar I disorder or schizophrenia. They must be diagnosed by DSM-5 criteria, have family support, and can't be a danger to themselves or others. Participants should either be on olanzapine already or not responding well to other antipsychotics.
What is being tested?
The study compares the effect of OLZ/SAM versus olanzapine alone on BMI Z-score in youth with schizophrenia or bipolar I disorder. It aims to see if OLZ/SAM leads to less weight gain than olanzapine, which is known for causing weight increase.
What are the potential side effects?
Possible side effects include weight gain, changes in metabolism leading to diabetes risk, drowsiness, increased appetite, dry mouth, restlessness and potential movement disorders among others typically associated with antipsychotic medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a teenager diagnosed with schizophrenia or bipolar I disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a long-acting injectable antipsychotic within the last 3 injection cycles.
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I have been diagnosed with depression or another mental health condition.
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I have had a severe head injury, seizure, or major neurological issue in the last year.
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My BMI is either above the 98th percentile or below the 5th percentile.
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I have been diagnosed with diabetes or prediabetes.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in body mass index (BMI) Zscore at week 12
Secondary study objectives
Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit
Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder
+3 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 OLZ/SAMExperimental Treatment1 Intervention
Fixed dose combination of olanzapine and samidorphan
Group II: Group 2 OlanzapineActive Control1 Intervention
Fixed dose of olanzapine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OLZ/SAM
2021
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
115 Previous Clinical Trials
26,759 Total Patients Enrolled
22 Trials studying Schizophrenia
5,877 Patients Enrolled for Schizophrenia
David McDonnell, MDStudy DirectorAlkermes, Inc.
6 Previous Clinical Trials
1,048 Total Patients Enrolled
4 Trials studying Schizophrenia
981 Patients Enrolled for Schizophrenia

Media Library

OLZ/SAM (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05303064 — Phase 3
Schizophrenia Research Study Groups: Group 1 OLZ/SAM, Group 2 Olanzapine
Schizophrenia Clinical Trial 2023: OLZ/SAM Highlights & Side Effects. Trial Name: NCT05303064 — Phase 3
OLZ/SAM (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303064 — Phase 3
~88 spots leftby Sep 2026
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