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Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression

NCT ID: NCT01115699

Last Updated: 2013-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-03-31

Brief Summary

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The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.

Detailed Description

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This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR\*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR\*D study.

The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.

Conditions

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Depression

Keywords

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Depression rTMS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Repetitive Transcranial Magnetic Stimulation

All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
* Must be able to continue to take same dose of duloxetine through the course of the study

Exclusion Criteria

* A history of failure for respond to Electroconvulsive Therapy (ECT)
* Any metal in the head (except in mouth)
* Implanted medication pump or cardiac pacemaker
* Have had prior brain surgery
* Have unprovoked seizure disorder or family history of treatment resistant epilepsy
* Pregnancy
* Psychiatric hospitalization within the past two weeks
* Suicide attempt with hospitalization within past three months
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuronetics

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David Mrazek

David Mrazek, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Mrazek, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10-000401

Identifier Type: -

Identifier Source: org_study_id