A Clinical Trial of Magnetic Stimulation in Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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 refractory to antidepressant medication.

Key facts

Study ID

NCT00711568

Run by

US Department of Veterans Affairs

People needed

48

Starts

2001-10-01

Expected to finish

2007-12-01

Last updated by the study team

2013-04-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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