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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03537794
Eligibility Criteria:
Inclusion Criteria:
* Key inclusion criteria for the MDD patients:
* DSM-5 criteria for a Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis (Sheehan et al, 2015)
* Age between 25 and 55 years
* Hamilton Depression Rating Scale - 17 item (HRSD-17; Hamilton, 1960) \> 14 (moderate to severe symptoms)
* Free of psychotropic medications for at least 5 half-lives before PET scanning
* Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
* For non-resistant patients: Previous history of response to an antidepressant, in order to increase signal to noise between resistant and non-resistant patients
Key inclusion criteria for the Healthy Controls:
* Ages between 25 and 55 years
* Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
Exclusion Criteria:
Key exclusion criteria for the MDD patients:
* Pregnancy/lactation
* Medical condition requiring immediate investigation or treatment
* Recent (\< 6 months)/current history of drug abuse/dependence
* Lifetime history of psychosis, other Axis I comorbidities are allowable
* Use of any psychotropic use within 5 half-lives before the PET scanning
* For non-resistant patients: Failure of \> 2 antidepressant treatments of adequate dose and duration for current MDE.
Key exclusion criteria for the Healthy Controls:
* Pregnancy/lactation
* Medical condition requiring immediate investigation or treatment
* Lifetime history of any psychiatric disorder
* Lifetime history of receiving an antidepressant
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT03537794
Study Brief:
Protocol Section:
NCT03537794