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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04509102
Eligibility Criteria:
Inclusion Criteria:
* All subjects will be between the ages of 18-65 and will meet DSM-V criteria for a current episode of major depressive disorder.
* Meet criteria for treatment resistance as defined by lack of response to two prior antidepressant trials at adequate dosage and duration. Participants may use any psychotropic medications other than psychostimulants or benzodiazepines, and may continue these medications during the study.
* The outside treating psychiatrist must agree that enrollment in the study is safe and acceptable for the subject.
Exclusion Criteria:
* Inability to give informed consent
* Lifetime diagnosis of bipolar affective disorder
* Lifetime diagnosis of major depressive disorder with psychotic features, schizophrenia, schizoaffective disorder, or any other psychotic disorder
* History of psychotic symptoms
* Lifetime diagnosis of substance use disorder
* History of stimulant misuse or abuse
* Active substance abuse
* Anxiety, tension, or agitation that is of sufficient severity to make it difficult for the subjects to tolerate psychostimulants and/or 10 Hz rTMS treatment
* Current use of psychostimulant medication
* Current use of benzodiazepines
* Current use of an Monoamine oxidase inhibitors (MAOI) or use of an MAOI within the past two weeks
* History of hypersensitivity to Adderall XR
* History of intolerance of any psychostimulant medication
* Pregnancy, breastfeeding, or plans to become pregnant during the study period
* Glaucoma
* Presence of motor tics or family history of tic disorder
* Symptomatic cardiovascular disease including hypertension, coronary artery disease, arteriosclerosis, cardiomyopathy, or arrhythmia
* Hyperthyroidism
* Structural cardiac abnormalities
* Family history of sudden cardiac death in a first degree relative
* History of epilepsy or seizure
* History of stroke
* History of brain tumor
* Presence of any metal in the head
* Presence of pacemaker or medical devices implanted close to the site of magnetic stimulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04509102
Study Brief:
Protocol Section:
NCT04509102