Exercise and Olanzapine-samidorphan
A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests olanzapine-samidorphan with aerobic exercise, which makes your heart beat faster. It is for 30 adults with schizophrenia, schizoaffective disorder, or bipolar I, II, or an unspecified type. Everyone will take the medicine for 8 weeks and do exercise for 4 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 65 years old and have one of the mental health conditions listed above.
- Have a body mass index (BMI), a measure of weight for height, from 18 to 40 at visits 1 and 2.
- Agree to join after learning about the study.
- Have stable physical and mental health.
- Have been helped by an antipsychotic medicine other than clozapine in the past 5 years.
- Have a reason to join and be likely to benefit, such as wanting a treatment change or a structured exercise program.
- Have had less than a 5% change in body weight over the past 3 months.
- If able to become pregnant, agree to use an approved birth control method during the study.
Who can't join
- Test positive for opioids, PCP, amphetamines, methamphetamine, or cocaine at either first visit; or have a moderate or severe substance use disorder or a serious eating disorder.
- Have used olanzapine-samidorphan in the past 6 months, had a poor response to olanzapine, or have no clear reason to expect it to help. Taking medicines that cannot be used with the study drug also rules you out.
- Have taken opioid medicines in the past 14 days, expect to need them during the study, or have taken opioid-blocking medicines such as naltrexone or naloxone in the past 60 days.
- Be pregnant or breastfeeding. People who can become pregnant must have negative blood and urine pregnancy tests at visits 1 and 2.
- Have a serious or unstable health problem that could make the medicine or exercise unsafe or affect results. Examples include certain heart, blood pressure, thyroid, brain, seizure, or movement problems, or a serious reaction to antipsychotic medicines in you or your family.
- Have thoughts of suicide with a plan or intent in the 3 months before visit 1 or at visit 2, or be considered unfit for the study by the study doctor.
- Have diabetes, bowel disease linked to weight loss, or unsafe blood test results involving the liver, kidneys, blood cells, blood fats, or blood sugar.
- Have joined a weight management program or greatly changed your diet or exercise in the past 6 weeks, or plan to join a weight management program during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age between 18-65, inclusive at Visit 1. 2. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I/II/NOS disorder at Visit 1. 3. Body Mass Index (BMI) of 18.0-40.0 kg/m2, inclusive, at Visits 1 and 2. 4. Willing to provide informed consent at Visit 1. 5. Medically and psychiatrically stable for study participation at Visit 1. 6. Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1. 7. Can benefit from participation in this study and has a reason to participate, such as inadequate efficacy on current treatment, side effects on current treatment, desire to start olanzapine-samidorphan or try structured exercise program (assessed at Visit 1). 8. Maintained a stable body weight (change \< 5%) for at least 3 months prior to Visit 1. 9. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only) (assessed at Visit 1 and Visit 2). Exclusion Criteria: 1. Positive drug screen for opioids, phencyclidine, amphetamine/ methamphetamine, or cocaine at Visit 1 or Visit 2. 2. Diagnosis of moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder or any other clinically significant eating disorder at Visit 1. 3. EKG abnormality that is clinically significant including a QT interval \> 450 msec for men and \> 470 msec for women, as corrected by the Fridericia formula (QTcF) at Visit 1. 4. Use of olanzapine+samidorphan for any reason in the last six months prior to Visit 1, any history of poor or inadequate response to treatment with olanzapine or no justifiable reason to expect improvement on olanzapine as assessed at Visit 1. 5. Taken opioid agonists (e.g., codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period (e.g., planned surgery), or has taken opioid antagonists including naltrexone (any formulations) or naloxone within 60 days prior to Visit 1. 6. Pregnant or breast feeding women. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2. 7. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise subject safety on study medication or exercise, or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following (as assessed at Visit 1): 1. Clinically significant hypotension or hypertension not stabilized on medical therapy. 2. Unstable thyroid dysfunction in the past 6 months (e.g., hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening). 3. Personal or family history of neuroleptic malignant syndrome, has a history of clinically significant extrapyramidal symptoms when taking olanzapine, or has had clinically significant tardive dyskinesia. 4. Neurological conditions include the following: * History of seizure disorder or a condition associated with seizures (except history of febrile seizures). * History of brain tumor, subdural hematoma, stroke or any other clinically significant neurological condition within the 12 months prior to Visit 1. * Head trauma with loss of consciousness within the 12 months prior to Visit 1. * Active, acute or chronic CNS infection. 5. Cardiac condition that might confound study results, pose additional risk when administering the study drug or exercise regimen to the subject, or preclude successful completion of the study. Conditions include the following: * Clinically significant cardiac arrhythmia, cardiomyopathy, a cardiac conduction defect, or a history of myocardial infarction or unstable angina within 6 months prior to Visit 1. 8. Currently taking any contraindicated medications as per the approved labeling for Olz-Sam (see section 6.5 for details) at Visit 1 and Visit 2. 9. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to Visit 1 or current at Visit 2 10. Inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss at Visit 1. 11. Joined a weight management program or had significant changes in diet or exercise regimen within 6 weeks prior to Visit 1 or plans to join a weight management program during the study as assessed at Visit 1. 12. History of diabetes (assessed at Visit 1). 13. Laboratory abnormality that would compromise the well-being of the subject, or any of the following specific laboratory results at Visit 1: 1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \> 2 times the upper limit of the laboratory normal reference range 2. Absolute neutrophil count (ANC) \<1.5 x 10\^3 μL 3. Platelet count \< 75 x 10\^3 uL 4. Serum creatinine \> 1.5 mg/dL 5. Dyslipidemia, defined for this study as total fasting cholesterol \> 280 mg/dL or fasting triglycerides \> 500 mg/dL 6. Hemoglobin A1c (HbA1c) \> 6.0% 7. Fasting plasma glucose \> 126 mg/dL (7.0 mmol/L) 14. Is not fit for the trial in the opinion of the investigator at Visit 1 and Visit 2.
Study sites (1)
NY
- New York State Psychiatric Institute · New York, NY 10032Megan Mayer, BA · Study contact · 646-774-8477 · megan.mayer@nyspi.columbia.eduMore trials in New York