A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

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Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active rTMS treatment

Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Group Type EXPERIMENTAL

Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Intervention Type DEVICE

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.

Sham rTMS treatment

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Group Type SHAM_COMPARATOR

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Intervention Type DEVICE

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

Interventions

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Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.

Intervention Type DEVICE

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Current major depressive disorder (MDD)
* Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
* On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
* Weight less than 350 pounds

Exclusion Criteria

* Current major depressive disorder episode of more than three years
* Seizure disorder
* History of brain injury, stroke or active central nervous system disease
* Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
* Active suicidal intent or plan
* Other significant psychiatric disorder
* Alcohol or substance dependence or abuse
* Prior treatment with transcranial magnetic stimulation
* Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
* If female, pregnant or lactating or planning to become pregnant within the next three months

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No