Back to resultsSafety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Open Label Active NeuroStar® TMS
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression
Eligibility Criteria
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).
Sites / Locations
- Dothan Behavioral Medicine
- UCLA
- Stanford University
- Rocky Mountain TMS
- Florida Clinical Practice Association, Inc.
- Anchor Neuroscience
- Beacon Medical Group
- Integrative Psychiatry
- Sheppard Pratt Health System
- Mayo Clinic
- University of Cincinnati College of Medicine
- The Ohio State University
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Sham Comparator
Other
Other
Arm Label
Phase I TMS Active
Phase I TMS Sham
Phase II Open Label Active TMS
Phase III Long-Term Follow up TMS Active
Arm Description
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Open label active TMS coil. Open label active NeuroStar® TMS.
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02586688
Brief Title
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Official Title
A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronetics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase I TMS Active
Arm Type
Active Comparator
Arm Description
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Arm Title
Phase I TMS Sham
Arm Type
Sham Comparator
Arm Description
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Arm Title
Phase II Open Label Active TMS
Arm Type
Other
Arm Description
Open label active TMS coil. Open label active NeuroStar® TMS.
Arm Title
Phase III Long-Term Follow up TMS Active
Arm Type
Other
Arm Description
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Intervention Type
Device
Intervention Name(s)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Other Intervention Name(s)
TMS, NeuroStar®
Intervention Description
Compare active NeuroStar® coil with sham NeuroStar® coil.
Intervention Type
Device
Intervention Name(s)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Other Intervention Name(s)
TMS, NeuroStar®
Intervention Description
Compare active NeuroStar® coil with sham NeuroStar® coil.
Intervention Type
Device
Intervention Name(s)
Open Label Active NeuroStar® TMS
Other Intervention Name(s)
TMS, NeuroStar®
Intervention Description
Open label NeuroStar® coil.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Croarkin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Heart
Organizational Affiliation
Neuronetics
Official's Role
Study Director
Facility Information:
Facility Name
Dothan Behavioral Medicine
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain TMS
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Florida Clinical Practice Association, Inc.
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Anchor Neuroscience
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Beacon Medical Group
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Integrative Psychiatry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40222
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17573044
Citation
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.
Results Reference
result
PubMed Identifier
22689344
Citation
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.
Results Reference
result
PubMed Identifier
21951987
Citation
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.
Results Reference
result
Learn more about this trial
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
We'll reach out to this number within 24 hrs