Study of Olanzapine-samidorphan with Aerobic Exercise to Prevent Early Weight Gain in Adults with Schizophrenia or Bipolar Disorder

What this Trial Is About

Researchers are evaluating the effects of combining olanzapine-samidorphan OlzSam with aerobic exercise on weight gain in people diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder types I, II, or NOS. The study aims to see if adding exercise reduces weight gain compared to historical data of OlzSam alone. This single-site, phase 4 trial focuses on treatment outcomes over an eight-week period. Participants will receive eight weeks of open-label OlzSam medication, with olanzapine doses adjusted by investigators during the first four weeks while samidorphan remains fixed at 10 mg. The first four weeks include aerobic exercise sessions 2 to 4 days per week. The study measures weight and metabolic changes at four and eight weeks, with cognitive assessments at baseline and study end. Throughout the trial, participants undergo medical and psychiatric screening, comprehensive weight, metabolic, and symptom evaluations before and after exercise, and cognitive tests. Researchers monitor weight change primarily at four weeks and secondarily at eight weeks. The total study duration for participants is eight weeks, during which their response to the combined treatment and exercise is carefully assessed.

Exercise and Olanzapine-samidorphan