OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder
Trial Summary
What is the purpose of this trial?
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it seems you can continue if you are currently treated with olanzapine. If you are on another antipsychotic, you may need to switch if it hasn't been effective.
What data supports the effectiveness of the drug OLZ/SAM for treating schizophrenia or bipolar disorder?
Is OLZ/SAM safe for humans?
OLZ/SAM, a combination of olanzapine and samidorphan, has been studied for its safety in humans, particularly for schizophrenia and bipolar I disorder. Research shows it aims to reduce weight gain associated with olanzapine while maintaining its effectiveness, and long-term studies have assessed its safety and tolerability over a year.12345
Research Team
David McDonnell, MD
Principal Investigator
Alkermes, Inc.
Eligibility Criteria
This trial is for young people aged 10-17 with bipolar I disorder or schizophrenia. They must be diagnosed by DSM-5 criteria, have family support, and can't be a danger to themselves or others. Participants should either be on olanzapine already or not responding well to other antipsychotics.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OLZ/SAM or olanzapine to evaluate weight gain as assessed by change in BMI Z-score
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olanzapine (Atypical Antipsychotic)
- OLZ/SAM (Atypical Antipsychotic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alkermes, Inc.
Lead Sponsor
Richard Pops
Alkermes, Inc.
Chief Executive Officer since 1991
BA in Economics from Stanford University
Dr. Craig Hopkinson
Alkermes, Inc.
Chief Medical Officer since 2017
MD