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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00616759
Eligibility Criteria:
Inclusion Criteria:
* Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR) criteria for major depression, single episode or recurrent
* Subjects must be over the age of 45 years
* Subjects must be willing to receive at least six treatments of ECT, along with pre ECT lab screening and pre and post psychological and neuropsychological tests
* The ability to read, speak and comprehend English and have the ability to complete the forms in writing
* Must be able to give consent for treatment
* Shorter acting benzodiazepines (aplrazolam, lorazepam) will be allowed on a prn basis but excluded 12 hours before each ECT session
Exclusion Criteria:
* Subjects who have a history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, or schizoaffective disorder, or who are exhibiting psychotic symptoms \[except mood congruent depressive delusions\].
* Subjects who have a substance abuse/dependence disorder not in full remission
* Patients with significant medical problems that may increase risk or require unusual concomitant treatment
* Patients with significant neurological problems including seizure disorder
* Patients with a hearing or visual impairment that would interfere with the research process
* Patients with moderate to severe dementia. Any patient scoring less than 25 on the MMSE will have a Mattis Dementia Rating Scale-2 (DRS-2) test for dementia administered.
* Patients known to be intolerant of propofol, etomidate, or succinylcholine, or for whom these anesthetic medications are not appropriate
* Patients taking anticonvulsant medications such as Tegretol, Depakote, Klonopin, etc.
* Patients on an involuntary admission status
* Patients unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT00616759
Study Brief:
Protocol Section:
NCT00616759