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Table 4 World Health Organization trial registration dataset

From: Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Data category Information
Primary registry and trial identifying number
Date of registration in primary registry 26 August 2010
Secondary identifying numbers None
Source(s) of monetary or material support Cooperative Studies Program, Department of Veterans Affairs
Primary sponsor Cooperative Studies Program, Department of Veterans Affairs
Secondary sponsor(s) None
Contact for public queries Gerald Georgette, RN
Contact for scientific queries Jerome Yesavage, MD
Phone: 650-852-3287
E-mail: Department of Psychiatry
Stanford University School of Medicine
3801 Miranda Avenue
Palo Alto, CA 94304, USA
Public title The Effectiveness of rTMS in Depressed VA Patients
Scientific title The Effectiveness of rTMS in Depressed VA Patients
Countries of recruitment USA
Health condition(s) or problem(s) studied Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
Treatment-Resistant Major Depression (TRMD)
Intervention(s) Active comparator: rTMS
Placebo comparator Sham rTMS
Key inclusion and exclusion criteria Inclusion Criteria
Between 18 and 80 years of age
Using the Structured Clinical Interview for DSM Disorders (SCID) for DSM-IV-TR patients will be diagnosed MDD
Have a HRSD24 ≥ 20 no more than 7 days prior to randomization
Exhibit moderate level of resistance to antidepressant treatment defined, using the ATHF, as failure of at least two adequate medication trials
Duration of current episode of MDD ≤ 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 to the study 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
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)
Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures
Have a cardiac pacemaker
Have an implanted device 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 > 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 Columbia Suicide Severity Rating Scale (CSSRS) or the endorsement of an actual attempt, interrupted attempt, or an aborted attempt in the past 6 months
Unstable cardiac disease or recent (<3 months previous) myocardial infarction Patient refuses to sign consent for participation in the study
Study type Interventional
Allocation: randomized
Intervention model: parallel assignment
Masking: double blind
Primary purpose: treatment
Phase III
Date of first enrollment June 2013
Target sample size 360
Recruitment status Stopped
Primary outcome(s) Proportion of subjects in each treatment group who achieve “remission” from depression at the end of the acute treatment phase
Key secondary outcomes The key secondary outcomes include:
Montgomery-Asberg Depression Rating Scales (MADRS), Beck Depression Inventory (BDI), Suicide Ideation measured by Beck Scale for Suicide Ideation (BSS), VR-36, and a neuropsychological battery