A Clinical Trial of Magnetic Stimulation in Depression

March 29, 2013 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
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)
20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes)
Device: Repetitive Transcranial Magnetic Stimulator
Repetitive Transcranial Magnetic Stimulator
EXPERIMENTAL: Arm 2
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)
20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes)
Device: Repetitive Transcranial Magnetic Stimulator
Repetitive Transcranial Magnetic Stimulator
SHAM_COMPARATOR: Arm 3
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Scale
Time Frame: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
Baseline x 2, end of treatment, one week, one month and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory
Time Frame: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
Baseline x 2, end of treatment, one week, one month and 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (ESTIMATE)

July 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2013

Last Update Submitted That Met QC Criteria

March 29, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBS-014-01S
  • Nadeau-573-08 (OTHER_GRANT: University of Florida)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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