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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00711568
Eligibility Criteria:
Inclusion Criteria:
* All patients will meet DSM-IV criteria for Major Depressive Episode (without psychotic features).
* All patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item Hamilton Rating Scale for Depression (HAM-D).
* All patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one SSRI) or will have been intolerant of at least three different antidepressant medications (including at least one SSRI).
Exclusion Criteria:
* Patient medications will be reviewed prior to enrollment in this study. Patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
* History of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
* Evidence of central nervous system disease based on baseline complete neurological examination, EEG and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
* History of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
* Axis II diagnosis of Cluster A (paranoid, schizoid, or schizotypal) or Cluster B (antisocial, borderline, histrionic, or narcissistic) personality disorder.
* Axis II diagnosis of mental retardation.
* History of schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse within the past year.
* Need for rapid clinical response due to conditions such as inanition, psychosis, or suicidality (defined as suicide attempt during the current major depressive episode or having a specific plan for committing suicide).
* A medical condition that is not well controlled, such as diabetes or hypertension, or concomitant medical or nutritional problems necessitating hospitalization.
* Patients taking anticonvulsant mood stabilizers (e.g. carbamazepine, valproic acid).
* Patients otherwise unable to grant informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00711568
Study Brief:
Protocol Section:
NCT00711568