VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Research data

Available Documentation

• Study protocol (PDF format)
• Statistical analysis plan (PDF format)
• Variable reference guide

Dates Data are Available

Currently available

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a request to Kousick.Biswas@va.gov. Investigators may be asked to provide further documentation such as a study proposal.

All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics

Objectives

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, and possibly have comorbid post-traumatic stress disorder (PTSD) and/or a history of substance abuse

Era of Service

All

Population

Male and female Veterans diagnosed with treatment-resistant major depression (TRMD) at VA medical centers.

All participants met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Major Depressive Disorder (MDD) and had failed at least two prior pharmacological interventions. Veterans with PTSD or history of substance use were not excluded.

Study Design

Randomized, double-blinded, intent-to-treat, two-arm, superiority parallel clinical trial

Interventions 

• Active comparator: rTMS
• Placebo comparator: Sham rTMS using placebo device that simulates active rTMS 

Time Period

July 2012 - March 2017

Setting

National

N

164 participants

Response Rate

Unconfirmed

Recruitment Method

Participants were recruited through multiple methods, including but not limited to: 

• Provider referral
• Flyers posted in VA hospitals
• Review of the VA administrative databases
• Mailed recruitment postcards

Staff at the clinical sites referred potential study participants. Study participants were selected from the entire cohort of patients referred for outpatient or inpatient psychiatric treatment at the clinical sites. The site investigators screened and consented participants in-person.  

Compensation

Participants were compensated for each stage reached in the study (range: $40-400):

• Up to 1 week of treatment: $40
• Treatment weeks 2-6: $300
• Follow-up visits 1-6: $60

Data Collected

Primary outcomes:

• Success or failure to achieve remission from depression, assessed by the Hamilton Rating Scale for Depression (HRSD24)

Secondary outcomes:

• Depression measured by Montgomery-Asberg Depression Rating Scale and the Beck Depression Inventory
• Suicidal ideation measured by Beck Scale for Suicide Ideation
• Quality of life measured by the Veterans RAND 36-Item Health Survey
• Cognitive function as measured by a neuropsychological battery 

Other assessments:

• Demographics, medical history, physical exam, laboratory, toxicology, pregnancy test and medication use
• Depression, suicidal ideation, hopelessness, and antidepressant treatment history
• Substance use and abuse, in particular alcohol abuse
• Trauma, life stressors, post-traumatic stress, and PTSD
• Experience, expression, and control of anger
• Cognitive impairment and function

Data Collection Methods

• Structured clinical interview for DSM-IV
• Medical records
• Laboratory reports
• Related documents from study sites

The CSP Coordinating Center (CSPCC) at Perry Point served as the centralized data management center for the study. Outcome measures were assessed at pre-, mid-, and several post-treatment time points.

Funding Sources

VA Cooperative Studies Program (CSP)

Investigator

Jerome A. Yesavage, MD

Contact

Kousick.Biswas@va.gov

Selected Publications

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;18(1):409.

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. Published online June 27, 2018.

More Information

• Study ClinicalTrials.gov site
• ClinicalTrials.gov Identifier: NCT01191333
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)