CSP #556 - The Effectiveness of rTMS in Depressed VA Patients

This study is currently recruiting participants.
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01191333
First received: August 26, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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. -


Condition Intervention Phase
Major Depressive Disorder
Device: rTMS
Device: Sham Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #556 - The Effectiveness of rTMS in Depressed VA Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Hamilton Rating scale for depression [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Scale for Suicide Ideation (BSI) [ Time Frame: Baseline - end of active treatment 4-6 weeks, then end of F/U 6 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline - end of active treatment 4-6 weeks, then end of F/U 6 months ] [ Designated as safety issue: No ]
  • VR-36 [ Time Frame: Baseline - end of active treatment 4-6 weeks, then end of F/U 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: July 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.
Device: rTMS
Repetitive Transcranial Magnetic Stimulation
Placebo Comparator: Arm 2
Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.
Device: Sham Device
Placebo Device that simulates active rTMS treatment

Detailed Description:

Major depression occurs in about 10% of American outpatients every year and of those, approximately 20% respond incompletely or not at all to trials of antidepressants, mood stabilizers, or psychotherapy (Kaplan and Sadock, 1996; Keller et al 1992; Thase, 2004). Treatment as usual for these cases of treatment resistant major depression (TRMD) frequently involves increased risks and increased side effects, such as those seen in monoamine oxidase inhibitors (MAOIs) and electroconvulsive therapy (ECT). New TRMD treatments are needed, preferably without major safety concerns or side effects as seen with aggressive polypharmacy or ECT.

Repetitive transcranial magnetic stimulation (rTMS) is a method of delivering brain stimulation without the seizures or risks associated with ECT, nor the potential side effects and risks of MAOI therapy. Systematic review and meta-analysis of the studies to date, which are typically of a small scale, appear to show a positive effect in TRMD (Martin et al. 2003). With a minimal side effect profile, and the rarity of untoward events and side-effects (Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS are considerably less than with ECT. Given this, rTMS has the potential to be a significant advance in care, if it were shown to be effective in TRMD in VA patients.

The trials of rTMS performed to date have not included participants with comorbid disorders, such as substance abuse and post-traumatic stress disorder (PTSD), thus the generalizability of their findings to a VA population is not clear. Further research including veterans with possible comorbid disorders is necessary, given the high rates of co-occurring substance abuse and PTSD that is present in the veteran population.

The present study is a randomized, controlled trial that compares active rTMS to a sham condition in veterans with treatment resistant major depression and possible comorbid post-traumatic stress disorder (PTSD) and / or a history of substance abuse. Veterans will remain under the care of their VA primary mental health provider throughout the project. Participants will be assessed at pre-, mid- and several post-treatment time points. This is a multisite trial that will be conducted at 9 VA Medical Centers around the country.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 80 years of age
  • Using the Structured Clinical Interview for DSM Disorders (SCID) for DSM-IV-TR (First et al. 2002) patients will be diagnosed MDD.
  • Have a HRSD24 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 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 your tubes tied)
  • Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.

Exclusion Criteria:

  • 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 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, 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 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 CSSRS 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191333

Contacts
Contact: Gerald Georgette, RN (650) 493-5000 ext 64073 Gerald.Georgette@va.gov

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304-1207
Contact: Gerald Georgette, RN    650-493-5000 ext 64073    Gerald.Georgette@va.gov   
Contact: Gerald Georgette, RN    (650) 493-5000 ext 64073    Gerald.Georgette@va.gov   
Study Chair: Jerome A. Yesavage, MD         
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: John Crisler    415-221-4810 ext 5844    john.crisler@va.gov   
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Deonna Suggs    513-861-3100 ext 5698    deonna.suggs@va.gov   
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristi Talley    215-823-5800 ext 2092    Kristi.Talley@va.gov   
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Andrei Liubomir Pisarov    412-360-2251    liubomir.pisarov@va.gov   
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Matt Schmidt    843-577-5011 ext 5209    Matthew.Schmidt@va.gov   
United States, Texas
Central Texas Veterans Health Care System, Temple, TX Recruiting
Temple, Texas, United States, 76504
Contact: Staley Justice    254-297-3951    staley.justice@va.gov   
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Lauren Forrest    801-386-4953    lauren.forrest@va.gov   
United States, Vermont
White River Junction VA Medical Center and Regional Office, White River Junction, VT Recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Janine Terry    802-295-9363 ext 5546    Janine.Terry@va.gov   
Sponsors and Collaborators
Investigators
Study Chair: Jerome A. Yesavage, MD VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01191333     History of Changes
Other Study ID Numbers: 556
Study First Received: August 26, 2010
Last Updated: March 19, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Mood Disorder
Depression
stress disorder, post-traumatic
Depressive Disorder
Stress Disorders, Traumatic
substance related disorders
Transcranial Magnetic Stimulation, repetitive
transcranial magnetic stimulation
veterans
mental health

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 20, 2014