Actively Recruiting
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Led by Alkermes, Inc. · Updated on 2026-05-06
220
Participants Needed
47
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
CONDITIONS
Official Title
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder diagnosed by DSM-5 criteria
- Outpatient or able to be treated as outpatient by study Week 2
- Reliable family or guardian support for outpatient management
- Currently treated with olanzapine or inadequate response to other antipsychotics
- Not a danger to self or others by investigator judgment
You will not qualify if you...
- Major depressive episode or other neuropsychiatric diagnosis interfering with study participation
- History of seizure disorder (except febrile seizures), severe head trauma with loss of consciousness within 12 months, or other significant neurological condition in past 12 months
- Current suicide risk as assessed by investigator or C-SSRS
- Received olanzapine for 14 days or more in the month prior or poor response to olanzapine
- Use of opioid agonists within 14 days (or 30 days for long-acting) prior to screening
- Anticipated opioid use during study (e.g., planned surgery)
- Use of opioid antagonists within 60 days prior to screening
- Use of long-acting injectable antipsychotics within 3 injection cycles prior to screening
- BMI percentile over 98th or under 5th
- Diagnosis of diabetes mellitus or prediabetes (HbA1c ≥ 6%) at screening
- Started smoking cessation or weight management program or major diet/exercise changes within 6 months or 6 weeks prior to screening
- Participation in another investigational study within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Alkermes Investigator Site
Dothan, Alabama, United States, 36303
Actively Recruiting
2
Alkermes Investigator Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Alkermes Investigator Site
Encino, California, United States, 91316
Withdrawn
4
Alkermes Investigator Site
Stanford, California, United States, 94305
Actively Recruiting
5
Alkermes Investigator Site
Upland, California, United States, 91786
Withdrawn
6
Alkermes Investigator Site
Colorado Springs, Colorado, United States, 80910
Withdrawn
7
Alkermes Investigator Site
Denver, Colorado, United States, 80202
Active, Not Recruiting
8
Alkermes Investigator Site
Hartford, Connecticut, United States, 06106
Withdrawn
9
Alkermes Investigator Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
10
Alkermes Investigator Site
Miami, Florida, United States, 33155
Withdrawn
11
Alkermes Investigator Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
12
Alkermes Investigator Site
Decatur, Georgia, United States, 30030
Actively Recruiting
13
Alkermes Investigator Site
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Alkermes Investigator Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
Alkermes Investigator Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
16
Alkermes Investigator Site
Lincoln, Nebraska, United States, 68526
Actively Recruiting
17
Alkermes Investigator Site
Omaha, Nebraska, United States, 68198
Withdrawn
18
Alkermes Investigator Site
Paramus, New Jersey, United States, 07652
Withdrawn
19
Alkermes Investigator Site
New York, New York, United States, 10016
Not Yet Recruiting
20
Alkermes Investigational Site
Kinston, North Carolina, United States, 28504
Withdrawn
21
Alkermes Investigator Site
Cincinnati, Ohio, United States, 45219
Actively Recruiting
22
Alkermes Investigator Site
West Chester, Ohio, United States, 45069
Actively Recruiting
23
Alkermes Investigator Site
DeSoto, Texas, United States, 75115
Terminated
24
Alkermes Investigator Site
Fort Worth, Texas, United States, 76104
Withdrawn
25
Alkermes Investigational Site
Richmond, Virginia, United States, 23220
Actively Recruiting
26
Alkermes Investigator Site
Everett, Washington, United States, 98201
Actively Recruiting
27
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina, 1900
Actively Recruiting
28
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina, C1199ABB
Actively Recruiting
29
Alkermes Investigator Site
Buenos Aires, Argentina, C1133AAH
Actively Recruiting
30
Alkermes Investigator Site
Córdoba, Argentina, X5003DCE
Actively Recruiting
31
Alkermes Investigator Site
Mendoza, Argentina, 5500
Actively Recruiting
32
Alkermes Investigator Site
Fortaleza, Ceará, Brazil, 60430-140
Actively Recruiting
33
Alkermes Investigator Site
Curitiba, Paraná, Brazil, 80240-280
Actively Recruiting
34
Alkermes Investigator Site
Goiânia, Brazil, 74093-040
Actively Recruiting
35
Alkermes Investigator Site
Rio de Janeiro, Brazil, 22270-060
Actively Recruiting
36
Alkermes Investigator Site
São Paulo, Brazil, 01228-000
Actively Recruiting
37
Alkermes Investigator Site
São Paulo, Brazil, 05403-010
Actively Recruiting
38
Alkermes Investigator Site
Barranquilla, Colombia, 110121
Actively Recruiting
39
Alkermes Investigator Site
Bello, Colombia, 51053
Actively Recruiting
40
Alkermes Investigator Site
Bogotá, Colombia, 111166
Actively Recruiting
41
Alkermes Investigator Site
Bogotá, Colombia, 80020
Actively Recruiting
42
Alkermes Investigator Site
Pereira, Colombia, 660003
Actively Recruiting
43
Alkermes Investigator Site
Culiacán, Mexico, 80230
Actively Recruiting
44
Alkermes Investigator Site
Estado de México, Mexico, C.P. 07000
Actively Recruiting
45
Alkermes Investigator Site
León, Mexico, 37000
Actively Recruiting
46
Alkermes Investigator Site
Monterrey, Mexico, 64620
Actively Recruiting
47
Alkermes Investigator Site
Monterrey, Mexico, 64710
Actively Recruiting
Research Team
G
Global Clinical Services
CONTACT
G
Global Clinical Services
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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