ClinicalTrials.gov
ClinicalTrials.gov Menu

Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02611206
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation intensities using a 3+3 study design for safety and tolerability amongst adolescents. This means that we will only enroll 3 participants at a time and give them rTMS at the stimulation intensity energy of 80% of motor threshold (MT). If all three participants complete the 6 weeks of treatment with no major safety events (i.e. seizure), we will increase the energy for the next 3 participants by 5%. If 1 of the 3 participants has a major safety event, we will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by 5% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of motor threshold. If 2 participants in each intensity level cohort experience a major safety event, we will discontinue running subjects at that energy level. If this happens at our initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the higher energy cohorts, we will return to the previous energy level and complete the remainder of the subjects at that energy level.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms
Study Start Date : October 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label rTMS
All participants who qualify will undergo 6 weeks of open-label rTMS.
Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression.
Other Name: Brainsway rTMS




Primary Outcome Measures :
  1. Change in score on Child Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]

Secondary Outcome Measures :
  1. Change in score Beck Depression Inventory (BDI-II) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]
  2. Change is score Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]
  3. Change in score Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]
  4. Change in score Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]
  5. Change in score Inventory of Depression and Anxiety Symptoms (IDAS) [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]
  6. Change in score Young Mania Rating Scale [ Time Frame: Baseline, post-rTMS, 6 Monthly FU Periods ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder (MDD)
  • A CDRS-R score of >40
  • Experiencing a current MDD episode with a duration of ≥ 4 weeks and ≤3 years
  • Resistance to treatment, defined by failure to respond adequately to at least one antidepressant treatment, defined by ATR level 1-4 in current episode
  • Both child and parent/guardian are English speaking
  • Female participants who are sexually active during the course of the study must use a form of birth control for the duration of the study

Exclusion Criteria:

  • Any subject with a clinically defined neurological disorder or insult including, but not limited to, a condition likely to increase the risk of seizure; such as, space occupying brain lesion; any history of seizure; history of cerebrovascular accident; transient ischemic attack within two years; cerebral aneurysm; dementia; brain surgery; history or stroke or family history of epilepsy
  • Any subject with an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
  • Positive responses to any question on the Transcranial Magnetic Stimulation Adult Safety Screening Questionnaire (TASS)
  • Subjects with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute unstable cardiac diseases
  • Subjects with conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed should be excluded. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes
  • Subjects with active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators
  • Inability to locate and quantify a motor threshold as defined in the protocol
  • History of treatment with ECT or TMS therapy for any disorders
  • Participation in any investigational drug trial within 4 weeks of the baseline visit
  • Pregnancy
  • IQ < 80
  • Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study
  • Suicide attempt within the previous 6 months that required medical treatment or ≥2 attempts in the past 12 months, or has a clear plan for suicide and states that s/he cannot guarantee that s/he 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
  • Unstable psychotherapy (therapy must be for at least 3 months prior to entry into the study, with no anticipation of change in the frequency or treatment focus of the therapeutic sessions over the duration of the study)
  • A diagnosis of substance use disorder, Schizophrenia, Bipolar Disorder, or Autism
  • Refusal to cooperate with study procedures
  • Recent change in dose of antidepressant medication (within 6 weeks prior to initial evaluation). This includes all antidepressants and any adjunctive psychotropic medications that are being used to address problems related to mood or anxiety (e.g. antipsychotic medications, mood stabilizers.) This does not include stimulant medications that are being used to treat Attention Deficit Hyperactivity Disorder (ADHD).**
  • Current treatment with Bupropion at a dose greater than 150mg per day.
  • Current treatment with a stimulant medication as an adjunct medication for depression.***
  • Current treatment with a stimulant medication for ADHD above FDA recommended dosages.***

(*) If the participant has an insufficient number of trials in the current episode, then the participant must also have failed ≥1 and ≤4 trials in a previous episode. Subjects who have been unable to complete an antidepressant trial of adequate dose and duration due to intolerance to antidepressant therapy may be included if they have demonstrated intolerance to ≥4 antidepressant medications within one discrete illness episode (current or previous episode as defined above)

(**) If there has been a recent discontinuation of a medication we will require varying lapses of time before study entry depending on medication type as follows: Antidepressant medications = 4 weeks, mood stabilizers (e.g. Lithium, Valproate) = 2 weeks, Antipsychotic medications = 2 weeks, Stimulant medications = 1 week

(***) If participants are being treated with stimulant medications as an adjunct strategy for their depression, we will require them to discontinue the stimulant prior to starting the study treatment and wait 1 week before they begin the study as listed above. If the participant is taking a stimulant medication to treat ADHD, they will be allowed to continue the stimulant medication, as long as the dosage is within FDA recommendations.


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): NCT02611206


Contacts
Contact: Kathryn R. Cullen, M.D. 612-273-9762 rega0026@umn.edu
Contact: Palistha Amatya, MD 612-626-8534 amaty008@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Kathryn R. Cullen, M.D.    612-273-9762    rega0026@umn.edu   
Contact: Palistha Amatya, MD    612-626-8534    amaty008@umn.edu   
Principal Investigator: Kathryn R. Cullen, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Kathryn R Cullen, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02611206     History of Changes
Other Study ID Numbers: 1505M71821
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
rTMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders