Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

January 31, 2018 updated by: Neuronetics

A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

Study Overview

Detailed Description

To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode (Phase I).

Secondary:

To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects.

To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) (Phase III).

To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) (Phase II).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Dothan, Alabama, United States, 36303
        • Dothan Behavioral Medicine
    • California
      • Los Angeles, California, United States, 90024
        • UCLA
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Rocky Mountain TMS
    • Florida
      • Gainesville, Florida, United States, 32606
        • Florida Clinical Practice Association, Inc.
      • Pensacola, Florida, United States, 32502
        • Anchor Neuroscience
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Beacon Medical Group
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Integrative Psychiatry
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati College of Medicine
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
  • Duration of current episode of depression ≥4 weeks and ≤3 years
  • Clinical Global Impression - Severity of Illness ≥ 4
  • Resistance to antidepressant treatment in a discrete illness episode
  • HAMD24 Item 1 ≥ 2 and total score ≥ 20
  • Subjects able to commit to protocol visit schedule
  • At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit

Exclusion Criteria:

  • Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)
  • Contraindication to TMS
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines
  • History of neurological disorder
  • Unstable medical conditions
  • Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.
  • Significant acute suicide risk
  • Inability to locate and quantify a motor threshold
  • If sexually active female, not on an accepted method of birth control.
  • Diagnoses of the following conditions (current unless otherwise stated):

    • Depression secondary to a general medical condition, or substance induced:
    • Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
    • Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,
    • Intellectually disabled,
    • Substance dependence or abuse within the past year (except nicotine or caffeine),
    • Bipolar disorder,
    • Obsessive compulsive disorder (lifetime),
    • Post-traumatic stress disorder (lifetime),
    • Eating disorder (lifetime).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phase I TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®
Sham Comparator: Phase I TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®
Other: Phase II Open Label Active TMS
Open label active TMS coil. Open label active NeuroStar® TMS.
Open label NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®
Other: Phase III Long-Term Follow up TMS Active
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Open label NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Paul Croarkin, MD, Mayo Clinic
  • Study Director: Karen Heart, Neuronetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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