OLZ/SAM for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Schizophrenia+1 More
OLZ/SAM - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Schizophrenia
  • Bipolar I Disorder

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 52 weeks

Up to 52 weeks
Incidence of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

All subjects
1 of 1

Experimental Treatment

236 Total Participants · 1 Treatment Group

Primary Treatment: OLZ/SAM · No Placebo Group · Phase 3

All subjects
Drug
Experimental Group · 1 Intervention: OLZ/SAM · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 52 weeks

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
112 Previous Clinical Trials
23,941 Total Patients Enrolled
22 Trials studying Schizophrenia
8,285 Patients Enrolled for Schizophrenia
David McDonnell, MDStudy DirectorAlkermes, Inc.
6 Previous Clinical Trials
1,041 Total Patients Enrolled
4 Trials studying Schizophrenia
965 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects who have completed the ALKS 3831-A312 study within 10 days of enrolling into this extension study.
The subject will benefit from continued therapy with OLZ/SAM.
You agree to abide by the contraception requirements specified in the protocol for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.