Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT06063369
Eligibility Criteria:
Inclusion Criteria:
1. Meet DSM V criteria for a Major Depressive Episode, with or without a diagnosis of Bipolar I or Bipolar II disorder.
2. Between 18-65 years of age, male or female subjects of any race.
3. Able to provide informed consent. All participant patients must have signed an informed consent document indicating they understand the purpose of the study and are willing to complying with the study procedures and restrictions.
4. Have a MADRS above 20 and an YMRS \< 12.
5. Inpatients or outpatients at the discretion of the investigator.
6. Live with a caregiver or have a relative/close friend who is in contact with them at least twice a week via phone.
Exclusion Criteria:
1. Diagnosis of schizophrenia or schizoaffective disorder
2. Women of child-bearing potential who do not practice contraception.
3. Women who are pregnant or breast-feeding.
4. Psychotic symptoms during the 2 weeks preceding the baseline day.
5. Failure of three or more antidepressant treatment trials.
6. Unstable medical disease (malignancy, poorly controlled diabetes, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Particular attention should be given to exclude patients with ischemic heart disease).
7. Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at the Screening Visit, as determined by the Investigator.
8. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
9. Patients with a current DSM-V substance or alcohol dependence.
10. Concurrent delirium, mental retardation, drug-induced psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06063369
Study Brief:
Protocol Section:
NCT06063369