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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT05767593
Eligibility Criteria:
Inclusion Criteria (Depressed Adults)
1. Age 18-65
2. Meet full DSM-5 diagnostic criteria for a current major depressive episode, as assessed by the MINI for DSM-5 or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) AND exhibit both:
1. Beck Depression Inventory score of 9 or higher.
2. Clinical Global Impressions Scale of 3 or higher.
3. If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
Inclusion Criteria (Healthy Controls)
1. Age 18-65
2. Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:
1. Beck Depression Inventory score of 8 or lower.
2. Clinical Global Impressions Scale of 2 or lower.
3. If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
Exclusion Criteria
1. A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome; a history of substance use disorder in the last 12 months.
2. Presence or history of clinically significant neurological disorders and brain injuries (cerebral infarction, cerebral hemorrhage, multiple sclerosis, epilepsy, etc.)
3. Serious medical illness or instability for which hospitalization may be likely within the next year.
4. Patient does not own a smartphone with a data plan that allows them to receive text messages and access the internet throughout the day.
5. Patient is unable to understand study procedures and participate in the informed consent process.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05767593
Study Brief:
Protocol Section:
NCT05767593