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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02462551
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 90 years (inclusive)
* Diagnosis of major depressive disorder (unipolar or bipolar) \[SCID to derive RDC; DSM-IV\]
* Pretreatment HRSD score ≥ 18 \[Hamilton Rating Scale for Depression (24-item)\]
* ECT indicated \[Physician evaluation\]
* Willing and capable of providing informed consent \[Physician evaluation\]
Exclusion Criteria:
* History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder \[SADS to derive RDC; rapid cycling defined as ≥ four episodes in past year\]
* History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) \[Physician evaluation; medical history\]
* Alcohol or substance abuse or dependence in the past year (RDC) \[Physician evaluation\]
* Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy \[Physician evaluation\]
* Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. \[Physician evaluation\]
* Unable to tolerate psychotropic washout and no psychotropic medication during the ECT trial, other than lorazepam (up to 3 mg/d PRN) \[Treatment history and physician evaluation\]
* ECT in the past six months \[Physician evaluation; medical history\]
* Has a cardiovascular and/or pulmonary condition \[Physician evaluation\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02462551
Study Brief:
Protocol Section:
NCT02462551