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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06795451
Eligibility Criteria:
Inclusion Criteria:
* 18 to 60 yrs., inclusive,
* Female or Male,
* With current MDD episode according to MINI 7.0.2. duration (≥4 weeks and
≤ 2 yrs.),
* Current BMI ≥18.5 and ≤ 35 kg/mts2, inclusive,
* MADRS score at screening ≥18
* Currently on an FDA- approved antidepressant medication at a stable therapeutic dose for ≥ 8 weeks,
* Psychotherapeutic interventions are allowed if dose/frequency stable for ≥4 weeks,
* Anxiety disorders allowed if no more than moderate in severity and are not the main diagnosis,
* Using an effective contraceptive method (participants with childbearing potential), and 10)Able to complete study related tasks.
Exclusion Criteria:
* Treatment resistance during current depressive episode (\>2 treatment trials at adequate doses/duration), including medication and neuromodulation treatments.
* Current/lifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders.
* Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year.
* Psychotic symptoms during the current MDD episode or in the past 6 months.
* Current (past month) substance use disorder (nicotine, caffeine allowed).
* Current unstable neurological conditions including seizure disorders (infantile seizures are not exclusionary), neurodegenerative disorders, or stroke.
* Evidence of severe peripheral neuropathy.
* History of moderate to severe traumatic brain injury (e.g., skull fracture or loss of consciousness \>10 minutes) or spinal cord injury.
* Unstable clinically significant medical conditions (e.g., uncontrolled hypertension as indicated by a systolic \>150 mmHg or diastolic \>95mmHg).
* History of cancer allowed if remitted for the past 5 years.
* Use of anticonvulsant medications and calcium channel blockers at screening.
* Current severe pain conditions or need for chronic use of pain medication including NSAIDs and opiates.
* Implanted electronic medical devices.
* Neuromodulation interventions in the past month.
* Active skin lesions on electrode placement sites.
* pregnant or breastfeeding.
* Suspected IQ \<80.
* Any other relevant clinical reason as judged by the clinician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06795451
Study Brief:
Protocol Section:
NCT06795451