Skip to main content
OpenTrials
Completed

NCT Number: NCT01909232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

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.

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

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.

Primary outcomes

  1. Change in depression severity

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

    Measured by the 24-item Hamilton Rating Scale for Depression

Secondary outcomes

  1. Change in depression severity

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

    Measured by the 24-item Hamilton Rating Scale for Depression

  2. Clinically significant response

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

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

  3. Clinically significant response

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

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

  4. Remission from depression

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

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

  5. Remission from depression

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

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

  6. Change in quality of life

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

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

  7. Change in quality of life

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

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

  8. Incidence of treatment-emergent adverse events and serious adverse events

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

Sponsors and collaborators

Lead sponsor

Cervel Neurotech, Inc.

Industry

Registry information

Official study title

A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2013
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.