Olanzapine-samidorphan + Exercise for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination treatment of olanzapine-samidorphan (a medication that helps manage mental health symptoms) and aerobic exercise for individuals with schizophrenia, schizoaffective disorder, or bipolar disorder. The aim is to determine if this combination can improve symptoms and overall well-being for those who haven't found relief with other treatments. The trial seeks participants with these conditions who have experienced limited success with their current medications or are interested in trying a structured exercise program. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.
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 is the safety track record for olanzapine-samidorphan plus exercise?
Research has shown that olanzapine-samidorphan is safe and well-tolerated over the long term. In studies lasting up to four years, patients maintained symptom control without major safety issues. One study found that after one year, it was generally well-tolerated, and patients' weight and overall health remained stable. These findings suggest that olanzapine-samidorphan consistently remains safe for many people over time.12345
Why are researchers enthusiastic about this study treatment?
Olanzapine-samidorphan is unique because it combines two active ingredients to tackle bipolar disorder with fewer side effects. Traditional treatments like lithium or valproate often come with weight gain and metabolic issues. However, olanzapine-samidorphan pairs an antipsychotic with samidorphan, which helps reduce these side effects while maintaining efficacy. Researchers are excited about this treatment because it offers a more balanced approach, potentially improving patient adherence and overall outcomes.
What evidence suggests that olanzapine-samidorphan plus exercise might be an effective treatment for bipolar disorder?
Research has shown that the combination of olanzapine and samidorphan (Olz/Sam) effectively manages symptoms in people with schizophrenia and bipolar I disorder. Studies have demonstrated that this treatment can control symptoms for several years. Specifically, one study found that patients required fewer emergency healthcare visits after starting this treatment. This combination aims to reduce the weight gain often associated with olanzapine alone. Overall, this treatment has been well-tolerated and helps maintain symptom control over the long term. Participants in this trial will receive olanzapine-samidorphan combined with an exercise regimen to evaluate its effectiveness for bipolar disorder.23678
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Olanzapine-samidorphan
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor