- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586688
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Dothan, Alabama, United States, 36303
- Dothan Behavioral Medicine
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California
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Los Angeles, California, United States, 90024
- UCLA
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Palo Alto, California, United States, 94305
- Stanford University
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Colorado
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Grand Junction, Colorado, United States, 81501
- Rocky Mountain TMS
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Florida
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Gainesville, Florida, United States, 32606
- Florida Clinical Practice Association, Inc.
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Pensacola, Florida, United States, 32502
- Anchor Neuroscience
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Indiana
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South Bend, Indiana, United States, 46601
- Beacon Medical Group
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Kentucky
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Louisville, Kentucky, United States, 40222
- Integrative Psychiatry
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Maryland
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Baltimore, Maryland, United States, 21285
- Sheppard Pratt Health System
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati College of Medicine
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Columbus, Ohio, United States, 43210
- The Ohio State University
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
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Other: Phase II Open Label Active TMS
Open label active TMS coil.
Open label active NeuroStar® TMS.
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Open label NeuroStar® coil.
Other Names:
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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.
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Open label NeuroStar® coil.
Other Names:
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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
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Croarkin, MD, Mayo Clinic
- Study Director: Karen Heart, Neuronetics
Publications and helpful links
General Publications
- Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
- O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. doi: 10.1002/da.21969. Epub 2012 Jun 11.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44-02219-000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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