Back to results

A Clinical Trial of Magnetic Stimulation in Depression

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

Repetitive Transcranial Magnetic Stimulator

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Hamilton Depression Scale

Secondary Outcome Measures

Beck Depression Inventory

Full Information

NCT ID

NCT00711568

First Posted

July 3, 2008

Last Updated

March 29, 2013

Sponsor

US Department of Veterans Affairs

Collaborators

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT00711568

Brief Title

A Clinical Trial of Magnetic Stimulation in Depression

Official Title

A Clinical Trial of Magnetic Stimulation in Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

Collaborators

University of Florida

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Despite the utility of modern psychotropic medications, depression remains a medical problem with major societal impact. Electroconvulsive therapy (ECT) is an effective somatic treatment for depression. However, ECT has disadvantages, including risks attendant with general anesthesia and significant cognitive side effects (e.g. confusion and memory loss). An effective but safer somatic therapy for depression could help many patients. The brain can be stimulated non-invasively by using time-varying magnetic fields to induce electrical currents within the cerebral cortex, a technique known as transcranial magnetic stimulation. Preliminary investigations have provided promising evidence of improved mood associated with high frequency repetitive transcranial magnetic stimulation (rTMS) of left prefrontal cortex in patients with medication-resistant major depression. However, the role of stimulus laterality in the effects of prefrontal rTMS have not been tested systematically. Furthermore, previous studies have likely been confounded by inadequate patient blinding and by a lack of standardization of psychotropic medication treatment. Therefore, we propose to use a carefully controlled clinical trial to directly test the hypothesis that the effects of prefrontal rTMS on mood are related to the laterality of magnetic stimulation. We also intend to improve blinding in comparison to previous studies by: 1) employing a parallel-group study design comparing real and simulated rTMS, as opposed to a crossover study design; 2) using specially constructed sham magnetic coils which can be placed directly on the scalp surface, to more effectively simulate rTMS; and 3) using trains of weak electrical impulses to simulate the cutaneous scalp stimulation associated with rTMS. We will minimize confounding effects of medications and antidepressant withdrawal by: 1) requiring that all patients have fail a monitored clinical trial of an SSRI or other comparable antidepressant prior to rTMS; and 2) continuing pharmacological treatment of depression during the rTMS phase of the trial. Demonstration of therapeutic efficacy of rTMS in this rigorously controlled clinical trial would provide a foundation for further investigation and development of this novel potential treatment modality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

depression, magnetic stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 3

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sham rTMS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulator

Intervention Description

Repetitive Transcranial Magnetic Stimulator

Primary Outcome Measure Information:

Title

Hamilton Depression Scale

Time Frame

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

Secondary Outcome Measure Information:

Title

Beck Depression Inventory

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen E. Nadeau, MD BS BS

Organizational Affiliation

North Florida/South Georgia Veterans Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Florida/South Georgia Veterans Health System

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10356626

Citation

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.

Results Reference

background

PubMed Identifier

24968008

Citation

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.

Results Reference

derived

PubMed Identifier

24769437

Citation

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.

Results Reference

derived

PubMed Identifier

20643486

Citation

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.

Results Reference

derived

Learn more about this trial

A Clinical Trial of Magnetic Stimulation in Depression

We'll reach out to this number within 24 hrs