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

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

June 30, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
SchizophreniaBipolar I Disorder
Interventions
DRUG

OLZ/SAM

OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.

DRUG

Olanzapine

The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day

Trial Locations (47)

1900

RECRUITING

Alkermes Investigator Site, La Plata

5500

RECRUITING

Alkermes Investigator Site, Mendoza

10016

NOT_YET_RECRUITING

Alkermes Investigator Site, New York

20010

RECRUITING

Alkermes Investigator Site, Washington D.C.

23220

RECRUITING

Alkermes Investigational Site, Richmond

28504

WITHDRAWN

Alkermes Investigational Site, Kinston

30030

RECRUITING

Alkermes Investigator Site, Decatur

33016

RECRUITING

Alkermes Investigator Site, Miami Lakes

33155

WITHDRAWN

Alkermes Investigator Site, Miami

36303

RECRUITING

Alkermes Investigator Site, Dothan

37000

RECRUITING

Alkermes Investigator Site, León

45069

RECRUITING

Alkermes Investigator Site, West Chester

45219

RECRUITING

Alkermes Investigator Site, Cincinnati

46202

RECRUITING

Alkermes Investigator Site, Indianapolis

51053

RECRUITING

Alkermes Investigator Site, Bello

60611

RECRUITING

Alkermes Investigator Site, Chicago

63304

RECRUITING

Alkermes Investigator Site, Saint Charles

64620

RECRUITING

Alkermes Investigator Site, Monterrey

64710

RECRUITING

Alkermes Investigator Site, Monterrey

68198

WITHDRAWN

Alkermes Investigator Site, Omaha

68526

RECRUITING

Alkermes Investigator Site, Lincoln

72204

RECRUITING

Alkermes Investigator Site, Little Rock

75115

TERMINATED

Alkermes Investigator Site, DeSoto

76104

RECRUITING

Alkermes Investigator Site, Fort Worth

80020

RECRUITING

Alkermes Investigator Site, Bogotá

80202

RECRUITING

Alkermes Investigator Site, Denver

80230

RECRUITING

Alkermes Investigator Site, Culiacán

80910

WITHDRAWN

Alkermes Investigator Site, Colorado Springs

91316

WITHDRAWN

Alkermes Investigator Site, Encino

91786

WITHDRAWN

Alkermes Investigator Site, Upland

94305

RECRUITING

Alkermes Investigator Site, Stanford

98201

RECRUITING

Alkermes Investigator Site, Everett

110121

RECRUITING

Alkermes Investigator Site, Barranquilla

111166

RECRUITING

Alkermes Investigator Site, Bogotá

660003

RECRUITING

Alkermes Investigator Site, Pereira

06106

WITHDRAWN

Alkermes Investigator Site, Hartford

07652

NOT_YET_RECRUITING

Alkermes Investigator Site, Paramus

C1199ABB

RECRUITING

Alkermes Investigator Site, La Plata

C1133AAH

RECRUITING

Alkermes Investigator Site, Buenos Aires

X5003DCE

RECRUITING

Alkermes Investigator Site, Córdoba

60430-140

RECRUITING

Alkermes Investigator Site, Fortaleza

80240-280

RECRUITING

Alkermes Investigator Site, Curitiba

74093-040

RECRUITING

Alkermes Investigator Site, Goiânia

22270-060

RECRUITING

Alkermes Investigator Site, Rio de Janeiro

01228-000

RECRUITING

Alkermes Investigator Site, São Paulo

05403-010

RECRUITING

Alkermes Investigator Site, São Paulo

C.P. 07000

RECRUITING

Alkermes Investigator Site, Estado de México

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY

NCT05303064 - Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder | Biotech Hunter | Biotech Hunter