Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorAlkermes, Inc.
About this trial
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
Subject has reliable family/legal guardian support available for outpatient management
Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
Disqualifiers
Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject has received olanzapine for >= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
Trial design
Design model
Parallel
Treatments tested in this trial
OLZ/SAM
DrugOLZ/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.
Olanzapine
DrugThe 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
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Group 1 OLZ/SAMExperimental treatment 1 intervention
Group B: Group 2 OlanzapineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
Change from baseline in waist circumference
To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine
Time frame
12 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov