Exercise and Olanzapine-samidorphan (NCT06740890) | Clinical Trial Compass
RecruitingPhase 4
Exercise and Olanzapine-samidorphan
United States30 participantsStarted 2025-06-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age between 18-65, inclusive at Visit 1.
✓. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I/II/NOS disorder at Visit 1.
✓. Body Mass Index (BMI) of 18.0-40.0 kg/m2, inclusive, at Visits 1 and 2.
✓. Willing to provide informed consent at Visit 1.
✓. Medically and psychiatrically stable for study participation at Visit 1.
✓. Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1.
✓. 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).
✓. Maintained a stable body weight (change \< 5%) for at least 3 months prior to Visit 1.
Exclusion criteria
✕. Positive drug screen for opioids, phencyclidine, amphetamine/ methamphetamine, or cocaine at Visit 1 or Visit 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.
✕. 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.
✕. 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.
✕. 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.
✕. 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.
✕. 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):
✕. Clinically significant hypotension or hypertension not stabilized on medical therapy.