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Magnetic Brain Stimulation for the Treatment of Adult Depression

NCT ID: NCT00149838

Last Updated: 2018-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-05-31

Brief Summary

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This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Detailed Description

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Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.

The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.

Conditions

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Depression

Keywords

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Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active prefrontal rTMS phase1

Phase I participants receiving rTMS

Group Type EXPERIMENTAL

Prefrontal rTMS

Intervention Type PROCEDURE

Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.

Sham rTMS phase 1

Phase I participants receiving sham stimulation

Group Type PLACEBO_COMPARATOR

Sham Stimulation

Intervention Type PROCEDURE

The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.

rTMS extension

rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS

Group Type EXPERIMENTAL

Prefrontal rTMS

Intervention Type PROCEDURE

Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.

Open label antidepressant regimen

All patients who met remission who were then transitioned to medications after the TMS trial was completed.

Group Type EXPERIMENTAL

Antidepressant Regimen

Intervention Type DRUG

Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

Interventions

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Prefrontal rTMS

Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.

Intervention Type PROCEDURE

Antidepressant Regimen

Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

Intervention Type DRUG

Sham Stimulation

The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.

Intervention Type PROCEDURE

Other Intervention Names

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TMS rTMS medication

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of major depression with a current episode
* Hamilton Rating Scale for Depression score higher than 20
* No response or intolerance to antidepressant medication in the current depressive episode

Exclusion Criteria

* Current use of antidepressants
* Diagnosis of psychosis or anxiety disorder
* Current substance abuse
* Seizures or history of head trauma
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark S. George, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Brain Stimulation Laboratory, Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.

Reference Type DERIVED
PMID: 23769413 (View on PubMed)

George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

Reference Type DERIVED
PMID: 20439832 (View on PubMed)

Other Identifiers

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R01MH069887

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A5-ETMA

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH069887

Identifier Type: NIH

Identifier Source: org_study_id

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