Olanzapine-samidorphan + Exercise for Bipolar Disorder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: New York State Psychiatric Institute

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

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

Body Mass Index (BMI) of 18.0-40.0 kg/m2 at Visits 1 and 2

Willing to provide informed consent at Visit 1

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

Exclusion Criteria

I do not have any health conditions that could worsen with study treatment.

I have a bowel condition that has caused me to lose weight.

Positive drug screen for opioids, phencyclidine, amphetamine/methamphetamine, or cocaine at Visit 1 or Visit 2

Treatment Details

Interventions

• Olanzapine-samidorphan (Antipsychotic)

Trial Overview The study tests the combination of Olz/Sam medication and aerobic exercise to see how they work together in treating patients with certain psychiatric disorders over a period of eight weeks at a single site.

Participant Groups

Group I: olanzapine-samidorphan plus exercise Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Dr. Elizabeth B. Ford

New York State Psychiatric Institute

Chief Medical Officer since 2023

MD

Dr. Joshua A. Gordon

New York State Psychiatric Institute

Chief Executive Officer

MD, PhD in Neuroscience