Phase 4 Bipolar Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 65 years old (inclusive).
• You have been diagnosed with schizophrenia, schizoaffective disorder, or Bipolar I, II, or Not Otherwise Specified (NOS) disorder.
• Your Body Mass Index (BMI) is between 18.0 and 40.0 (a measure of body weight relative to height).
• You are willing to give your informed consent to participate.
• You are considered medically and mentally stable enough to take part in the study.
• You have responded to an antipsychotic medication (other than clozapine) at some point in the past 5 years.
• You have a meaningful reason to participate, such as your current treatment not working well enough, experiencing side effects, or wanting to try a structured exercise program or a specific medication.
• Your body weight has been stable (changed less than 5%) for at least the past 3 months.
• If you are a woman who could become pregnant, you are willing to use an approved form of contraception for the entire study.

Who may not be able to join:

• You test positive for opioids, PCP, amphetamines/methamphetamine, or cocaine at the screening visits.
• You have been diagnosed with a moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder, or another significant eating disorder.
• You have a significant heart rhythm abnormality detected on an ECG (heart tracing) test, including a specific electrical measurement (QT interval) that is too long (confirm with trial site).
• You have used the combination medication olanzapine+samidorphan in the past six months, have previously responded poorly to olanzapine, or there is no clear reason to expect olanzapine to help you.
• You have taken opioid pain medications (such as codeine, oxycodone, tramadol, or morphine) in the past 14 days, expect to need them during the study (for example, due to planned surgery), or have taken opioid-blocking medications like naltrexone or naloxone in the past 60 days.
• You are currently pregnant or breastfeeding, or you test positive on a pregnancy test at the screening visits.
• You have an unstable or significant medical condition that could make participation unsafe, including uncontrolled high or low blood pressure, unstable thyroid problems in the past 6 months, a history of a serious reaction to antipsychotic medications, certain neurological conditions (such as seizure disorders, brain tumors, recent stroke, or active brain infection), or significant heart conditions such as heart attack or unstable chest pain within the past 6 months.
• You are currently taking any medications that are known to interact badly with the study drug olanzapine+samidorphan.
• You have had thoughts of suicide with a specific intent or plan in the past 3 months, or have such thoughts at the time of your second screening visit.
• You have inflammatory bowel disease or another digestive condition linked to weight loss.
• You have recently joined a weight management program or made major changes to your diet or exercise routine within the past 6 weeks, or plan to do so during the study.
• You have a history of diabetes.
• Your blood test results show certain abnormalities, including liver enzyme levels more than twice the normal range, low white blood cell counts, low platelet counts, high creatinine (a kidney marker), very high cholesterol or triglycerides (blood fats), a blood sugar control marker (HbA1c) above 6.0%, or a fasting blood sugar level above 126 mg/dL.
• The trial doctor does not consider you suitable for the study for any other medical reason.

Important: Always verify eligibility with the trial site directly before applying.