To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
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.
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
Change from baseline in body mass index (BMI) Zscore at week 12
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Time frame: 12 weeks
Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12
To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine
Time frame: 12 weeks
Time to all-cause discontinuation of study drug over 52 weeks
To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine
Time frame: Up to 52 weeks
Change from baseline in waist circumference
To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine
Time frame: 12 weeks
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit
To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia
Time frame: 12 weeks
Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder
To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder
Time frame: 12 weeks
Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit
To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder
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Alkermes Investigator Site
Dothan, Alabama, United States
RECRUITINGAlkermes Investigator Site
Little Rock, Arkansas, United States
RECRUITINGAlkermes Investigator Site
Encino, California, United States
WITHDRAWNAlkermes Investigator Site
Stanford, California, United States
RECRUITINGAlkermes Investigator Site
Upland, California, United States
WITHDRAWNAlkermes Investigator Site
Colorado Springs, Colorado, United States
WITHDRAWNAlkermes Investigator Site
Denver, Colorado, United States
RECRUITINGAlkermes Investigator Site
Hartford, Connecticut, United States
WITHDRAWNAlkermes Investigator Site
Washington D.C., District of Columbia, United States
RECRUITINGAlkermes Investigator Site
Miami, Florida, United States
WITHDRAWN...and 37 more locations
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: Up to 52 weeks