Status:
COMPLETED
A Clinical Trial of Magnetic Stimulation in Depression
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
University of Florida
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether repetitive high field transcranial magnetic stimulation of the left or right frontal lobes is beneficial for the treatment of depression that is refra...
Detailed Description
Despite the utility of modern psychotropic medications, depression remains a medical problem with major societal impact. Electroconvulsive therapy (ECT) is an effective somatic treatment for depressio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00711568
Start Date
October 1 2001
End Date
December 1 2007
Last Update
April 1 2013
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608