RECRUITING

Exercise and Olanzapine-samidorphan

Conditions

Schizophenia Disorder Schizoaffective Disorder Bipolar Disorder I or II Bipolar Disorder NOS Exercise Antipsychotic induced weight gain olanzapine-samidorphan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-15

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06740890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Megan Mayer, BA

CONTACT

646-774-8477

megan.mayer@nyspi.columbia.edu

Joshua T Kantrowitz, MD

CONTACT

646-774-6738

joshua.kantrowitz@nyspi.columbia.edu

Study Locations (Sites)

New York State Psychiatric Institute

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-15

Study Completion Date2027-04

Study Record Updates

Study Start Date2025-06-15

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Exercise
Antipsychotic induced weight gain
olanzapine-samidorphan

Additional Relevant MeSH Terms

Schizophenia Disorder
Schizoaffective Disorder
Bipolar Disorder I or II
Bipolar Disorder NOS