Actively Recruiting
Exercise and Olanzapine-samidorphan
Led by New York State Psychiatric Institute · Updated on 2025-07-11
30
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise and Olanzapine-samidorphan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years inclusive at Visit 1
- Diagnosis of schizophrenia, schizoaffective disorder, or Bipolar I/II/NOS disorder at Visit 1
- Body Mass Index (BMI) between 18.0 and 40.0 kg/m2 inclusive at Visits 1 and 2
- Willingness to provide informed consent at Visit 1
- Medically and psychiatrically stable for study participation at Visit 1
- Responsive to antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1
- Has a reason to participate such as inadequate efficacy or side effects on current treatment, desire to start olanzapine-samidorphan, or try structured exercise program
- Maintained stable body weight (less than 5% change) for at least 3 months prior to Visit 1
- Willing to use qualified contraception methods during study (for women of childbearing potential)
You will not qualify if you...
- Positive drug screen for opioids, phencyclidine, amphetamine/methamphetamine, or cocaine at Visits 1 or 2
- Diagnosis of moderate/severe substance use disorder or any significant eating disorder at Visit 1
- Clinically significant EKG abnormalities including QT interval >450 msec (men) or >470 msec (women) at Visit 1
- Use of olanzapine-samidorphan in last 6 months or history of poor response to olanzapine
- Use of opioid agonists within 14 days prior to Visit 1 or anticipated need for opioids during study
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy tests at Visits 1 and 2
- Clinically significant or unstable medical illnesses compromising safety or study evaluation
- Currently taking contraindicated medications for Olz-Sam at Visits 1 and 2
- Suicidal ideation with intent or plan in past 3 months or current at Visit 2
- Inflammatory bowel disease or gastrointestinal disorders causing weight loss at Visit 1
- Participation in weight management program or major diet/exercise changes within 6 weeks prior to Visit 1 or planned during study
- History of diabetes at Visit 1
- Laboratory abnormalities including elevated liver enzymes, low neutrophil or platelet counts, high creatinine, dyslipidemia, elevated HbA1c or fasting glucose at Visit 1
- Deemed unfit for the trial by investigator at Visits 1 and 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New York State Psychiatric Institute
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Megan Mayer, BA
CONTACT
J
Joshua T Kantrowitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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