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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02859103
Eligibility Criteria:
Inclusion/exclusion criteria for MDD patients (n=40) are as follows:
Inclusion Criteria
1. DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis
2. Age between 18 and 60 years
3. Hamilton Depression Rating Scale - 17 item (HRSD-17)58 \> 17 (moderate to severe symptoms)
4. Free of psychotropic medications for at least 5 half-lives before baseline visit
5. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
Exclusion Criteria
1. Pregnancy/lactation
2. Medical condition requiring immediate investigation or treatment
3. Recent (\< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
4. Lifetime history of psychosis, other Axis I comorbidities are allowable
5. Significant Axis II diagnosis
6. Previous intolerance or failure to respond to an adequate trial of desvenlafaxine
7. Failure of \> 2 antidepressant treatments of adequate dose and duration for current MDE
Inclusion/exclusion criteria for Healthy Controls (n=20) are as follows:
Inclusion Criteria
1. Age between 18 and 60 years
2. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
Exclusion Criteria
1. Pregnancy/lactation
2. Medical condition requiring immediate investigation or treatment
3. Lifetime history of any psychiatric disorder
4. Lifetime history of receiving an antidepressant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02859103
Study Brief:
Protocol Section:
NCT02859103