NCT01191333

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 2, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 7, 2018

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

4.6 years

First QC Date

August 26, 2010

Results QC Date

January 10, 2018

Last Update Submit

February 8, 2018

Conditions

Major Depressive Disorder

Keywords

Mood DisorderDepressionstress disorder, post-traumaticDepressive DisorderStress Disorders, Traumaticsubstance related disordersTranscranial Magnetic Stimulation, repetitivetranscranial magnetic stimulationVeteransmental health

Outcome Measures

Primary Outcomes (1)

  • The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression

    The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.

    End of acute treatment 4-6 weeks

Secondary Outcomes (5)

  • Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS)

    End of acute treatment 4-6 weeks, then end of F/U 6 months

  • Mean Depression Score as Assessed by Beck Depression Inventory (BDI)

    Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months

  • Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS)

    End of acute treatment 4-6 weeks, then end of F/U 6 months

  • Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS)

    End of acute treatment 4-6 weeks, then end of F/U 6 months

  • Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS)

    End of acute treatment 4-6 weeks, then end of F/U 6 months

Study Arms (2)

Active rTMS

EXPERIMENTAL

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

Sham rTMS

PLACEBO COMPARATOR

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

Interventions

rTMSDEVICE

Repetitive Transcranial Magnetic Stimulation

Active rTMS
Sham DeviceDEVICE

Placebo Device that simulates active rTMS treatment

Sham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (2)

  • Mi Z, Biswas K, Fairchild JK, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Georgette G, Beale T, Pittman D, McNerney MW, Rosen A, Huang GD, George M, Noda A, Yesavage JA. Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 2;18(1):409. doi: 10.1186/s13063-017-2125-y.

    PMID: 28865495BACKGROUND

  • Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS; VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483.

    PMID: 29955803DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorMood DisordersDepressionStress Disorders, Post-TraumaticDepressive DisorderStress Disorders, TraumaticSubstance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorTrauma and Stressor Related DisordersChemically-Induced DisordersPersonal Satisfaction

Results Point of Contact

Title
Jerome Yesavage, MD
Organization
Director, VISN21 MIRECC, Department of Veterans Affairs
Jerome.Yesavage@va.gov
650-852-3287

Study Officials

  • Jerome A. Yesavage, MD

    VA Palo Alto Health Care System, Palo Alto, CA

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 30, 2010

Study Start

July 2, 2012

Primary Completion

February 15, 2017

Study Completion

March 31, 2017

Last Updated

March 9, 2018

Results First Posted

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(9)