Olanzapine-samidorphan + Exercise for Bipolar Disorder
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain medications like opioid agonists or antagonists before and during the study. It's best to discuss your current medications with the trial team to see if they are allowed.
What data supports the effectiveness of the drug Olanzapine-samidorphan for treating bipolar disorder?
Is the combination of olanzapine and samidorphan safe for humans?
How is the drug olanzapine-samidorphan unique for treating bipolar disorder?
Olanzapine-samidorphan is unique because it combines olanzapine, which is effective for treating bipolar disorder, with samidorphan, which helps reduce the weight gain often caused by olanzapine. This combination aims to provide the benefits of olanzapine while minimizing its common side effect of weight gain.12345
What is the purpose of this trial?
This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise.
Eligibility Criteria
This trial is for individuals with schizophrenia, schizoaffective disorder, or bipolar I/II/NOS. Participants will engage in an 8-week treatment with Olanzapine-samidorphan (Olz/Sam) combined with a 4-week aerobic exercise program.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 8 weeks of open label Olz/Sam, with 4 weeks of aerobic exercise
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olanzapine-samidorphan
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor