Table 4 World Health Organization trial registration dataset

Primary registry and trial identifying number

ClinicalTrials.gov

NCT01191333

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

650-849-1942

Gerald.Georgette@va.gov

Contact for scientific queries

Jerome Yesavage, MD

Phone: 650-852-3287

E-mail: yesavage@stanford.edu 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