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

Study 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.Check my eligibility
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.See study design
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
Select...
I am a teenager diagnosed with schizophrenia or bipolar I disorder.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in body mass index (BMI) Zscore at week 12
Secondary outcome measures
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
+4 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

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
114 Previous Clinical Trials
26,596 Total Patients Enrolled
David McDonnell, MDStudy DirectorAlkermes, Inc.
6 Previous Clinical Trials
1,048 Total Patients Enrolled

Media Library

OLZ/SAM (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05303064 — Phase 3
Bipolar Disorder Research Study Groups: Group 1 OLZ/SAM, Group 2 Olanzapine
Bipolar Disorder 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

Frequently Asked Questions

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

At how many different locations is this trial being conducted?

"There are 7 sites where this trial is running, with more locations in Anaheim, Long Beach and Everett. If you want to participate in the trial, it would be best to choose a location near you to cut down on travel time."

Answered by AI

The upper age limit for this trial is 30 years old, correct?

"To be clear, this study only enrolls patients aged 10-17. Out of the 807 clinical trials for patients over 65, 306 are for those under 18 years old."

Answered by AI

Are there currently any open slots for new participants in this trial?

"According to the official website, this trial is looking for more participants and was last updated on 9/29/2022. The listing was first posted on 6/30/2022."

Answered by AI

To be eligible for this trial, what are the requirements that potential participants must meet?

"This trial is looking for 220 participants with a diagnosis of schizophrenia between the ages of 10 and 17. In order to be eligible, applicants must meet the following criteria: have reliable family/legal guardian support available for outpatient management, currently treated with olanzapine or another antipsychotic that has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment, not be a danger to self or others (per Investigator judgement), subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder diagnosed according to DSM-5 criteria"

Answered by AI

Has the FDA cleared OLZ/SAM for use?

"OLZ/SAM's Phase 3 status indicates that while there is data supporting efficacy, there are also multiple rounds of data confirming its safety. Consequently, our team at Power has given it a score of 3."

Answered by AI

Could you give me an estimate of how many patients are in this trial?

"The clinical trial mentioned is, in fact, recruiting patients as of now. More specifically, the study was posted on June 30th of this year and edited September 29th. The recruitment goal for the trial is 220 participants from 7 different locations."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Washington
Ohio
What site did they apply to?
Alkermes Investigator Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I've been taking zyprexa for years would like to try something new.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

DO YOU THINK IM A GOOD FIT?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
2022. "Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05303064.
All > Weight Gain > Schizophrenia
~123 spots leftby Sep 2026
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