NCT00711568

Brief Summary

The purpose of this study is to determine whether repetitive high field transcranial magnetic stimulation of the left or right frontal lobes is beneficial for the treatment of depression that is refractory to antidepressant medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2001

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
Last Updated

April 1, 2013

Status Verified

March 1, 2013

Enrollment Period

5.8 years

First QC Date

July 3, 2008

Last Update Submit

March 29, 2013

Conditions

Depression

Keywords

depressionmagnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale

    Baseline x 2, end of treatment, one week, one month and 3 months post-treatment

Secondary Outcomes (1)

  • Beck Depression Inventory

    Baseline x 2, end of treatment, one week, one month and 3 months post-treatment

Study Arms (3)

Arm 1

EXPERIMENTAL

Left dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli

Procedure: Repetitive transcranial magnetic stimulation (rTMS)Device: Repetitive Transcranial Magnetic Stimulator

Arm 2

EXPERIMENTAL

Right dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli

Procedure: Repetitive transcranial magnetic stimulation (rTMS)Device: Repetitive Transcranial Magnetic Stimulator

Arm 3

SHAM COMPARATOR

Left or right dorsolateral frontal 20 Hz sham TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli

Procedure: Sham rTMS

Interventions

Repetitive transcranial magnetic stimulation (rTMS)PROCEDURE

20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes)

Arm 1Arm 2
Sham rTMSPROCEDURE

20 Hz sham rTMS delivered to L or R frontal region for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli

Arm 3
Repetitive Transcranial Magnetic StimulatorDEVICE

Repetitive Transcranial Magnetic Stimulator

Arm 1Arm 2

Eligibility Criteria

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

You may qualify if:

  • All patients will meet DSM-IV criteria for Major Depressive Episode (without psychotic features).
  • All patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item Hamilton Rating Scale for Depression (HAM-D).
  • All patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one SSRI) or will have been intolerant of at least three different antidepressant medications (including at least one SSRI).

You may not qualify if:

  • Patient medications will be reviewed prior to enrollment in this study. Patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
  • History of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
  • Evidence of central nervous system disease based on baseline complete neurological examination, EEG and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
  • History of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
  • Axis II diagnosis of Cluster A (paranoid, schizoid, or schizotypal) or Cluster B (antisocial, borderline, histrionic, or narcissistic) personality disorder.
  • Axis II diagnosis of mental retardation.
  • History of schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse within the past year.
  • Need for rapid clinical response due to conditions such as inanition, psychosis, or suicidality (defined as suicide attempt during the current major depressive episode or having a specific plan for committing suicide).
  • A medical condition that is not well controlled, such as diabetes or hypertension, or concomitant medical or nutritional problems necessitating hospitalization.
  • Patients taking anticonvulsant mood stabilizers (e.g. carbamazepine, valproic acid).
  • Patients otherwise unable to grant informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (4)

  • Triggs WJ, McCoy KJ, Greer R, Rossi F, Bowers D, Kortenkamp S, Nadeau SE, Heilman KM, Goodman WK. Effects of left frontal transcranial magnetic stimulation on depressed mood, cognition, and corticomotor threshold. Biol Psychiatry. 1999 Jun 1;45(11):1440-6. doi: 10.1016/s0006-3223(99)00031-1.

    PMID: 10356626BACKGROUND

  • Nadeau SE, Bowers D, Jones TL, Wu SS, Triggs WJ, Heilman KM. Cognitive effects of treatment of depression with repetitive transcranial magnetic stimulation. Cogn Behav Neurol. 2014 Jun;27(2):77-87. doi: 10.1097/WNN.0000000000000031.

    PMID: 24968008DERIVED

  • Nadeau SE, Davis SE, Wu SS, Dai Y, Richards LG. A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke. Neurorehabil Neural Repair. 2014 Nov-Dec;28(9):885-95. doi: 10.1177/1545968314532032. Epub 2014 Apr 26.

    PMID: 24769437DERIVED

  • Triggs WJ, Ricciuti N, Ward HE, Cheng J, Bowers D, Goodman WK, Kluger BM, Nadeau SE. Right and left dorsolateral pre-frontal rTMS treatment of refractory depression: a randomized, sham-controlled trial. Psychiatry Res. 2010 Aug 15;178(3):467-74. doi: 10.1016/j.psychres.2010.05.009. Epub 2010 Jun 18.

    PMID: 20643486DERIVED

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Stephen E. Nadeau, MD BS BS

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

October 1, 2001

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

April 1, 2013

Record last verified: 2013-03

Locations

US(1)