Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder
A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression
1 other identifier
interventional
286
1 country
13
Brief Summary
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect. It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Jan 2004
13 active sites
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
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 2, 2005
CompletedFirst Posted
Study publicly available on registry
March 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedSeptember 20, 2013
September 1, 2013
1.8 years
March 2, 2005
September 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions
4 to 6 weeks
Secondary Outcomes (3)
Safety and tolerability of rTMS
screening through 30 days past last day of participation
Change in depressive symptomatology with rTMS
acute phase
Short term durability of rTMS efficacy
during 3 week taper
Study Arms (2)
TMS
ACTIVE COMPARATORRepetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 6 weeks
Placebo
PLACEBO COMPARATORTreatment 5 days/week for up to 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4
- Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full criteria for the DSM-IV definition of major depressive episode);
- Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit;
- Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF criteria to at least 1 and no more than 4 drug trials in a previous episode.
- Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF criteria for a single adequate treatment trial in the current episode.
- Capable and willing to provide informed consent
- Signed HIPAA authorization
- Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy
- If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
You may not qualify if:
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- Seasonal pattern of depression as defined by DSM-IV
- History of substance abuse or dependence within the past year (except nicotine and caffeine)
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes
- Bipolar disorder
- Eating disorder (current or within the past year)
- Obsessive compulsive disorder (lifetime)
- Post-traumatic stress disorder (current or within the past year)
- An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- Any history of seizure EXCEPT those therapeutically induced by ECT
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuroneticslead
Study Sites (13)
PsyCare
Poway, California, 92064, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Northwestern University School of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UVA Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903, United States
Related Publications (6)
Janicak PG, Nahas Z, Lisanby SH, Solvason HB, Sampson SM, McDonald WM, Marangell LB, Rosenquist P, McCall WV, Kimball J, O'Reardon JP, Loo C, Husain MH, Krystal A, Gilmer W, Dowd SM, Demitrack MA, Schatzberg AF. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010 Oct;3(4):187-99. doi: 10.1016/j.brs.2010.07.003. Epub 2010 Aug 11.
PMID: 20965447DERIVEDDemitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.
PMID: 19629020DERIVEDSimpson KN, Welch MJ, Kozel FA, Demitrack MA, Nahas Z. Cost-effectiveness of transcranial magnetic stimulation in the treatment of major depression: a health economics analysis. Adv Ther. 2009 Mar;26(3):346-68. doi: 10.1007/s12325-009-0013-x. Epub 2009 Mar 28.
PMID: 19330495DERIVEDAvery DH, Isenberg KE, Sampson SM, Janicak PG, Lisanby SH, Maixner DF, Loo C, Thase ME, Demitrack MA, George MS. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. J Clin Psychiatry. 2008 Mar;69(3):441-51. doi: 10.4088/jcp.v69n0315.
PMID: 18294022DERIVEDJanicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.
PMID: 18232722DERIVEDO'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PMID: 17573044DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2005
First Posted
March 3, 2005
Study Start
January 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
September 20, 2013
Record last verified: 2013-09