← Back to Search

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
Subject is able to be treated on an outpatient basis.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

Study Summary

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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can receive treatment without staying in the hospital.

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
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)
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
113 Previous Clinical Trials
26,500 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

Frequently Asked Questions

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

What are the requirements to participate in this research project?

"To be eligible for this research, participants must have a diagnosis of schizophrenia and be aged between 10 and 17 years old. Up to 236 patients will be enrolled in this clinical trial."

Answered by AI

Is this study only meant for elderly patients?

"This upcoming clinical trial is only open to patients aged 10 to 17. Out of the 230 total trials, this is the 49th one specifically for those under 18 and the 181st for patients over 65."

Answered by AI

Are there any available openings for new participants in this experiment?

"The clinical trial in question, which was last updated on February 9th, 2022, is not presently looking for candidates. However, there are 357 other trials that are."

Answered by AI

Has the FDA cleared OLZ/SAM for therapeutic use?

"Based on our team's estimation, OLZ/SAM falls on the safe side of things because it is a Phase 3 trial. This means that, while there is some data supporting its efficacy, there is also multiple rounds of data supporting its safety."

Answered by AI
~138 spots leftby Sep 2027