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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT02196259
Eligibility Criteria:
Control Group:
Inclusion Criteria:
(4) Ability to tolerate small, enclosed spaces without anxiety; (6) English fluency.
Exclusion Criteria:
* Pregnant or trying to become pregnant.
* history of serious head injury;
* possibility of ferrous metals within the body, e. g. aneurysm clips, retained particles; or metal that would impair the magnetic resonance (MR) signal, e.g., some dental hardware;
* Smoking usage \> 10 cigarettes per day
* Daily intake of caffeine exceeds 2 cups of coffee per day
* Unstable cardiac problems (e.g. severe or poorly treated hypertension, unstable arrhythmia, etc.) or concurrent medications for which anesthesia would be contraindicated
* Patients with a current general medical illness that is life threatening or inadequately treated will be excluded: moderate-to-severe chronic pain, evidence of fracture or malignancy, inflammatory joint disease, severe physical impairment (e.g., bilateral amputation, blindness), morbid obesity, autoimmune/inflammatory diseases, cardiopulmonary disorders (i.e., angina, congestive heart failure, COPD), chronic renal insufficiency, uncontrolled endocrine or allergic disorders (i.e., hyper-/hypothyroidism, diabetes, allergic rhinitis), malignancy.
* Taking any medication, prescription or non-prescription, with psychotropic effects.
* History of psychiatric or neurological illness; History of substance abuse or dependence Positive urine toxicology screen.
Refractory Depression Group:
* Meets all above control group screening criteria except history of psychiatric illness and prescription medication usage
* Included subjects will have a Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of major depressive disorder, recurrent or chronic, moderate-to-severe, without psychotic features, with medication resistance, accepted with agreement by two different psychiatrists. For this study, treatment resistance is defined as ≥2 failed adequate antidepressant trials.
* Patients with a DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder will be excluded. Any history of antidepressant- or substance- induced hypomania or mania will be excluded.
* Subjects will be free of comorbid substance abuse or dependence for at least 3 months, with a negative urine toxicology screen.
* No current suicide plan or intent.
* Comorbid Axis I anxiety disorder diagnoses will be permitted if they do not require current treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02196259
Study Brief:
Protocol Section:
NCT02196259