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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04031157
Eligibility Criteria:
Inclusion Criteria:
* Male and female at the age of 18 - 75 years old at time of screening.
* MDD diagnosis per DSM V at screening visit or prior to screening visit.
* Rule out other causes of depressive symptoms other than MDD.
* Ability to read, understand and sign an informed consent document
* Female subjects at reproductive age that are tested negative for pregnancy
* Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration
Exclusion Criteria:
* Patient is currently on an antidepressant treatment.
* Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
* requires antipsychotic medication or mood stabilizers.
* Patient is at substantial suicidal risk as judged by the treating physician
* Patient has attempted suicide in the past year.
* Patient has any current unstable medical condition or surgical illness.
* Patient has history of seizure or convulsions.
* Patient has history of drug abuse or alcoholism in the last 6 months.
* Inadequate communication with the patient.
* Patient has participated in another clinical study in the last 30 days preceding this study.
* In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04031157
Study Brief:
Protocol Section:
NCT04031157