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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Neuronetics
Study ID
NCT02586688
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Active NeuroStar® Transcranial Magnetic Stimulation (TMS) — DEVICE
    Compare active NeuroStar® coil with sham NeuroStar® coil.
  • Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) — DEVICE
    Compare active NeuroStar® coil with sham NeuroStar® coil.

Study Details

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).

Key Dates

Start date
Oct 31, 2015
Status verified
May 2025
Primary completion
Jan 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Phase I TMS Active
    Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
  • Sham Comparator: Phase I TMS Sham
    Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Primary Outcome Measure

Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value. [ Time Frame: 6 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Dothan Behavioral MedicineDothanAlabama36303-
UCLALos AngelesCalifornia90024-
Stanford UniversityPalo AltoCalifornia94305-
Rocky Mountain TMSGrand JunctionColorado81501-
Florida Clinical Practice Association, Inc.GainesvilleFlorida32606-
Anchor NeurosciencePensacolaFlorida32502-
Beacon Medical GroupSouth BendIndiana46601-
Integrative PsychiatryLouisvilleKentucky40222-
Sheppard Pratt Health SystemBaltimoreMaryland21285-
Mayo ClinicRochesterMinnesota55905-
University of Cincinnati College of MedicineCincinnatiOhio45219-
The Ohio State UniversityColumbusOhio43210-
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Dothan, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Dothan Behavioral Medicine· Dothan, ALUCLA· Los Angeles, CAStanford University· Palo Alto, CARocky Mountain TMS· Grand Junction, COFlorida Clinical Practice Association, Inc.· Gainesville, FLAnchor Neuroscience· Pensacola, FL

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