The Effectiveness of rTMS in Depressed VA Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic Stimulation (rTMS) helps people with depression who have not been helped by medications or who have not been helped enough by medications.

Key facts

Study ID

NCT01191333

Run by

VA Office of Research and Development

People needed

164

Starts

2012-07-02

Expected to finish

2017-03-31

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and 80 years of age
• Using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) for DSM-IV-TR (First et al. 2002) patients will be diagnosed Major Depressive Disorder (MDD).
• Have a Hamilton Rating Scale for Depression (HRSD-24) score greater or equal to 20 no more than 7 days prior to randomization.
• Exhibit moderate level of resistance to antidepressant treatment defined, using the Antidepressant Treatment History Form (ATHF) (Sackeim et al. 1990), as failure of at least two adequate medication trials.
• Duration of current episode of less than or equal to 10 years.
• Ability to obtain a Motor Threshold (MT) (should be determined at the end of the screening process).
• Currently under the care of a VA psychiatrist.
• If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to randomization and patient will be willing to remain on a stable regimen during the acute treatment phase.
• Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
• For female participants, agrees to use one of the following acceptable methods of birth control
• Complete abstinence (not having sexual intercourse with anyone)
• An oral contraceptive (birth control pills)
• Norplant
• Depo-Provera
• A condom with spermicide
• A cervical cap with spermicide
• A diaphragm with spermicide
• An Intrauterine device
• Surgical sterilization (having tubes tied)
• Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.

You may not qualify if…

• Pregnant or lactating female (This is an FDA-required exclusion. In the future, if rTMS becomes a proven treatment for major depression, its safety in the context of pregnancy should be studied separately (Nahas et al. 1999).
• Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures. For the purpose of this study, those medications are listed in Appendix G (for example, theophylline).
• Have a cardiac pacemaker.
• Have an implanted device (deep brain stimulation) or metal in the brain.
• Have a cochlear implant.
• Have a mass lesion, cerebral infarct, increased intracranial pressure, or other active central nervous system (CNS) disease, including a seizure disorder.
• Known current psychosis as determined by DSM-IV or SCID (axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
• Known current Bipolar I disorder as determined by SCID or a History of Bipolar I disorder.
• Current amnestic disorders, dementia, Blessed Orientation-Memory-Concentration (BOMC) greater than 10, delirium, or other cognitive disorders.
• Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via SCID, within 3 months prior to screening.
• Patients with an elevated risk of seizure due to traumatic brain injury (TBI).
• Participation in another concurrent clinical trial.
• Patients with prior exposure to rTMS.
• Active current suicidal intent or plan as evidenced by a score of 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or the endorsement of an actual attempt, interrupted attempt, or an aborted attempt in the past 6 months. All patients will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial (See Section X.B.8).
• Unstable cardiac disease or recent (< 3 months previous) myocardial infarction.
• Patient refuses to sign consent for participation in the study.

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• Philadelphia VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• Central Texas Veterans Health Care System, Temple, TX — Temple, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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