RecruitingPhase 4NCT06740890

Exercise and Olanzapine-samidorphan

A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain


Sponsor

New York State Psychiatric Institute

Enrollment

30 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding a structured exercise program to a new antipsychotic medication (olanzapine-samidorphan, which is designed to cause less weight gain than standard olanzapine) helps reduce weight gain and metabolic side effects in people with schizophrenia, schizoaffective disorder, or bipolar disorder. **You may be eligible if...** - You are between 18 and 65 years old - You have a DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder - Your BMI is between 18.0 and 40.0 kg/m² - You have responded to an antipsychotic medication (other than clozapine) in the past 5 years - You are medically and psychiatrically stable **You may NOT be eligible if...** - You have only responded to clozapine - Your BMI is outside the 18.0–40.0 range - You have serious medical conditions that would prevent safe exercise participation - You are not stable enough to participate in the study activities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlanzapine-samidorphan + exercise

8 weeks of open label Olanzapine-samidorphan + 4 weeks of aerobic exercise


Locations(1)

New York State Psychiatric Institute

New York, New York, United States

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NCT06740890


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