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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT02489305
Eligibility Criteria:
Inclusion Criteria:
* Participants must have met Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-V) criteria for diagnosis of nonpsychotic MDD within the past 2 years (that is, the start of the most recent major depressive episode (MDE) must be less than or equal to 24 Months before screening), as confirmed using the MINI International Neuropsychiatric Interview (MINI - DSM-V). MDD must be recurrent, rather than a single episode
* During the most recent MDE, participant must have responded to, and must be continuing to receive and respond to, an oral antidepressant treatment regimen (given at an adequate dosage and duration based on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire), within the past 3 months. A change in the oral antidepressant treatment regimen since the time of achieving response in the most recent episode will be allowed
* Participants must have a Montgomery Asberg Depression Rating Scale total score less than or equal to 14
* Participant must be willing and able to complete self-reported assessments via a study-specific smartphone, and must be willing to wear an wrist actigraphy device for the duration of the study
Exclusion Criteria:
* Participant has any of the following DSM-V psychiatric diagnoses: MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), schizophrenia, or schizoaffective disorder
* Participant has a history of drug or alcohol use, with a severity of at least moderate or severe, according to DSM-V criteria, within 6 months before screening
* Participant is currently receiving or has received vagal nerve stimulation (VNS), electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) or deep brain stimulation (DBS) for the most recent MDE
* Participant is currently receiving stimulants, anticonvulsants, or mood stabilizers for treatment of his or her MDD
* Participant is a woman who is pregnant, or planning to become pregnant, while enrolled in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02489305
Study Brief:
Protocol Section:
NCT02489305