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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03999567
Eligibility Criteria:
Inclusion Criteria:
* The participant is able and willing to provide informed consent.
* The participant is male or female 18-65 years of age and owns a smart phone.
* The participant has received a current diagnosis of a major depressive episode (MDE) as part of MDD as per DSM-5 criteria.
* The participant's current MDE is confirmed by the M.I.N.I.
* The participant is an outpatient of a psychiatric setting.
* The participant has a MADRS score ≥ 20 at screening and baseline.
* At least one prior MDE formally diagnosed by a healthcare provider or validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).
Exclusion Criteria:
* Current alcohol and/or substance use disorder as confirmed by the M.I.N.I.
* Presence of comorbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the M.I.N.I.
* Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
* Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function.
* Use of benzodiazepines within 12 hours of cognitive assessments.
* Consumption of alcohol within 8 hours of cognitive assessments.
* Inconsistent use or abuse of marijuana.
* Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
* Diagnosed reading disability or dyslexia.
* Clinically significant learning disorder by history.
* Electroconvulsive therapy (ECT) in the last 6 months.
* History of moderate or severe head trauma (e.g., loss of consciousness for \>1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
* Pregnant and/or breastfeeding.
* Received investigational agents as part of a separate study within 30 days of the screening visit.
* Actively suicidal/presence of suicidal ideation or evaluated as being a suicide risk (as per clinical judgment using the Columbia-Suicide Severity Rating Scale).
* Currently receiving treatment with Monoamine Oxidase Inhibitors anti-depressants, antibiotics such as linezolid, or intravenous methylene blue.
* Previous hypersensitivity reaction to vortioxetine or any components of the formulation.
* Clinical worsening symptoms of depression and suicide risk based on investigator judgement.
* History of or current diagnosis of Serotonin syndrome.
* History of or current Abnormal bleeding.
* Previous history or current symptoms of mania/hypomania.
* Angle closure glaucoma.
* Hyponatremia.
* Moderate hepatic impairment.
* History of seizures and epilepsy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03999567
Study Brief:
Protocol Section:
NCT03999567