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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02586688
Recruitment Status : Unknown
Verified January 2018 by Neuronetics.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Neuronetics

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE October 26, 2015
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
HAMD24 total score change from baseline value. [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Official Title  ICMJE A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
    Compare active NeuroStar® coil with sham NeuroStar® coil.
    Other Names:
    • TMS
    • NeuroStar®
  • Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
    Compare active NeuroStar® coil with sham NeuroStar® coil.
    Other Names:
    • TMS
    • NeuroStar®
  • Device: Open Label Active NeuroStar® TMS
    Open label NeuroStar® coil.
    Other Names:
    • TMS
    • NeuroStar®
Study Arms  ICMJE
  • Active Comparator: Phase I TMS Active
    Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
    Intervention: Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
  • Sham Comparator: Phase I TMS Sham
    Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
    Intervention: Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
  • Phase II Open Label Active TMS
    Open label active TMS coil. Open label active NeuroStar® TMS.
    Intervention: Device: Open Label Active NeuroStar® TMS
  • 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.
    Intervention: Device: Open Label Active NeuroStar® TMS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02586688
Other Study ID Numbers  ICMJE 44-02219-000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neuronetics
Study Sponsor  ICMJE Neuronetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Croarkin, MD Mayo Clinic
Study Director: Karen Heart Neuronetics
PRS Account Neuronetics
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP