OLZ/SAM

DRUG4 trials

Sponsors

Alkermes, Inc.

Conditions

Bipolar 1 DisorderBipolar I DisorderSchizophreniaSchizophrenia Disorder

Phase 1

Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

CompletedNCT04987658

Alkermes, Inc.Bipolar I Disorder

Start: 2021-07-22End: 2023-08-11Updated: 2023-11-22

Phase 3

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Enrolling by invitationNCT04987229

Alkermes, Inc.Bipolar I Disorder, Schizophrenia

Start: 2021-10-22End: 2027-09-01Target: 236Updated: 2026-08-14

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

RecruitingNCT05303064

Alkermes, Inc.Bipolar I Disorder, Schizophrenia

Start: 2022-06-30End: 2026-09-01Target: 220Updated: 2026-08-14

Unknown Phase

An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)

Alkermes, Inc.Bipolar 1 Disorder, Schizophrenia Disorder

Updated: 2026-08-04