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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT03742557
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-65 years
2. MDD diagnosis as provided by DSM-5 criteria
3. TRD as defined by failure to achieve response to two consecutive antidepressant therapies at an adequate dose and duration
4. Patients approving inclusion by signing the informed consent
Exclusion Criteria:
1. Comorbidity with other mental and neurological disorders (except generalized anxiety disorder)
2. Substance use disorders at least 3 months prior to enrollment
3. Evidence of structural abnormalities in basal MRI
4. Pregnancy or lactation
5. Hypersensitivity to ketamine
6. Cardiac failure
7. Personal history of psychosis
8. First-degree relatives with history of psychosis
9. Uncontrolled close-angle glaucoma
10. Neurological disease (present)
11. Uncontrolled Hypertension
12. Contraindications for the realization of H1-MRS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03742557
Study Brief:
Protocol Section:
NCT03742557