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Trial record 6 of 59 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Minnesota, United States ) | NIH, U.S. Fed

Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression

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ClinicalTrials.gov Identifier: NCT03363919
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Neuronetics
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic

Brief Summary:
The Researchers are going to gather information regarding the use of rTMS as a treatment for depression in adolescents with Major Depressive Disorder. The researchers also hope to learn if measures of brain activity (cortical excitability and inhibition) collected with transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit from certain types of rTMS treatment.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: NeuroStar TMS Therapy® System Device: NeuroStar XPLOR® Not Applicable

Detailed Description:
Phase I is a double-blind, randomized, biomarker-stratified trial of 1 Hz vs. 10 Hz rTMS. Phase II is for participants who do not respond to Phase I treatment and is a biomarker guided, double-blind trial of continuous vs intermittent theta burst stimulation (TBS). Please note that transcranial magnetic stimulation (TMS) biomarkers will be collected in this protocol during the course of the proposed interventions. Participants in Phase I will be offered enrollment in a separate protocol with baseline and posttreatment 7 Tesla Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) scans

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: In both phases of the study (phase I and phase II) participants and study team members completing clinical rating scales will be blinded to treatment assignment. The study team member completing clinical rating scales and analyzing TMS neurophysiology measures will not be allowed in the treatment suite during therapeutic rTMS sessions (10 Hz, 1 Hz, iTMS, or cTBS).
Primary Purpose: Treatment
Official Title: Glutamatergic and GABAergic Biomarkers in rTMS for Adolescent Depression
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 Hz left prefrontal rTMS
36 sessions of 1 Hz rTMS at 120% motor threshold applied to the left prefrontal cortex. Each session is 2400 continuous pulses.
Device: NeuroStar TMS Therapy® System
The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with MDD who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.

Device: NeuroStar XPLOR®
NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.

Active Comparator: 10 Hz left prefrontal rTMS
36 sessions of 10 Hz rTMS at 120% motor threshold applied to the left prefrontal cortex. Each session is 2400 pulses with 4 seconds on and 36 seconds off.
Device: NeuroStar TMS Therapy® System
The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with MDD who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.

Device: NeuroStar XPLOR®
NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.




Primary Outcome Measures :
  1. Total Children's Depression Rating Scale, Revised (CDRS-R) score [ Time Frame: up to 6 weeks ]
    The children's depression Rating Scale-Revised (CDRS-R) (Poznanski and Mokros 1996) has become the most widely used rating scale for assessing severity of depression and change in depressive symptoms for clinical research trials in children and adolescents with depression. The CDRS-R, which was based on the adult Hamilton Depression Rating Scale, was originally developed as a rating scale for children aged 6-12 years. It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms)


Secondary Outcome Measures :
  1. Intracortical Facilitation ICF [ Time Frame: Weekly for 6 weeks ]
    Intracortical Facilitation will be the secondary continuous outcome measure. A within-Participants linear mixed model analysis of repeated measures will be used to examine the change in ICF over 6 weeks of rTMS treatment in depressed adolescents. We will consider the inclusion of pubertal state and treatment resistance (as defined by ATHF score) during the study period as a covariate in the mixed model. A mixed model analysis will be conducted on ICF for those who receive 6 weeks of low frequency (1 Hz) rTMS treatment (Hypothesis 2a) and, in a separate model, for those who receive 6 weeks of high frequency (10 Hz) rTMS treatment (Hypothesis 2c).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Depressed adolescent participants will have a primary diagnoses of MDD based on a clinical and structured interview with the MINI
  • Depression symptoms severity of a 40 or greater based on evaluation with the Children's Depression Rating Scale Revised (CDRS-R) at screening and baseline visits. Further, the total score of the baseline CDRS-R score must not have had a 25% or greater decrease from the screening CDRS-R score
  • The duration of the current episode of depression must be 4 weeks or more but 3 years or less.
  • For any participant currently receiving antidepressant medication, the referring clinician must determine that insufficient benefit is being received from this treatment and it is clinically appropriate to discontinue the existing antidepressant.
  • Participants in psychotherapy are eligible provided that this was initiated 4 weeks prior to enrollment and that the frequency of visits will be maintained during study participation.

Exclusion criteria:

  • The following psychiatric comorbidities are exclusionary: psychotic disorders, bipolar disorders, anorexia nervosa, bulimia nervosa, and substance use disorders within the past year (with the exception of caffeine and tobacco)
  • A positive urine drug screen at baseline
  • Seizure history
  • Family history of epilepsy in a first degree relative
  • Head trauma with loss of consciousness for greater than 5 minutes
  • Any true positive findings on the rTMS safety screening form.
  • Any concurrent psychotropic medications (for potential participants receiving antidepressants or psychotropic medications, the referring clinician must determine that insufficient benefit is being received from the treatment and if clinically appropriate, discontinue existing antidepressants and other psychotropic medications)
  • Prohibited concomitant medications (See Appendix A)
  • Pregnancy or suspected pregnancy in female Participants (assessed with urine pregnancy test)
  • Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the subject's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes.
  • Prior brain surgery
  • Risk for increased intracranial pressure such as a brain tumor
  • Any unstable medical condition
  • History of treatment with ECT or TMS Therapy for any disorder
  • Use of any investigational drug within 4 weeks of the baseline visit
  • Initiation of a new psychotherapeutic treatment within the past 4 weeks
  • Suicide attempt within the previous 6 months that required medical treatment or ≥ 2 attempts in the past 12 months, or has a clear cut plan for suicide and states that he/she cannot guarantee that he/she will inform a family member or call his/her psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or, in the investigator's opinion, is likely to attempt suicide within the next 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363919


Contacts
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Contact: Majorie Gresbrink (507) 255-0624 Gresbrink.Marjorie@mayo.edu
Contact: Paul Croarkin, DO (507) 293-2557 croarkin.paul@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Majorie Gresbrink    507-255-0624    Gresbrink.Marjorie@mayo.edu   
Contact: Paul E Croarkin, DO    (507) 293-2557    croarkin.paul@mayo.edu   
Principal Investigator: Paul E Croarkin, DO         
Sponsors and Collaborators
Mayo Clinic
National Institute of Mental Health (NIMH)
Neuronetics
Investigators
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Principal Investigator: Paul E Croarkin, DO Mayo Clinic

Publications:

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Responsible Party: Paul E. Croarkin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03363919     History of Changes
Other Study ID Numbers: 17-004958
1R01MH113700-01 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Paul E. Croarkin, Mayo Clinic:
adolescent
biomarkers

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders