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

N/ACompletedNCT01909232

Cervel Neurotech, Inc.92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depressive Disorder, Major

Interventions

Active Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDEVICE

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.

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (6)

Emory University

Atlanta, Georgia, United States

Sheppard-Pratt Health System

Baltimore, Maryland, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Outcomes

Primary Outcomes

Change in depression severity

Measured by the 24-item Hamilton Rating Scale for Depression

Time frame: Baseline to four weeks (the conclusion of rTMS treatment)

Secondary Outcomes

Change in depression severity

Measured by the 24-item Hamilton Rating Scale for Depression

Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

Clinically significant response

Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score

Time frame: Baseline to four weeks (the conclusion of rTMS treatment)

Clinically significant response

Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score

Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

Remission from depression

Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10

Time frame: Baseline to four weeks (the conclusion of rTMS treatment)

Remission from depression

Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10

Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

Change in quality of life

Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form

Time frame: Baseline to four weeks (the conclusion of rTMS treatment)

Data from ClinicalTrials.gov

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