Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01502033
First received: December 27, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression.


Condition Intervention
Major Depressive Disorder
Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) post Treatment 30 or Last Treatment (in cases of early withdrawal) [ Time Frame: Within 5 days of Treatment 30 or Last Treatment ] [ Designated as safety issue: Yes ]
    The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.


Secondary Outcome Measures:
  • Mean change from baseline in Clinical Global Impression - Severity (CGI-S) post Treatment 30 or Last Treatment (in cases of early withdrawal) [ Time Frame: Within 5 days of Treatment 30 or Last Treatment ] [ Designated as safety issue: Yes ]
    The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis.

  • Mean change from baseline in Clinical Global Impression - Improvement (CGI-I) post Treatment 30 or Last Treatment (in cases of early withdrawal) [ Time Frame: Within 5 days of Treatment 30 or Last Treatment ] [ Designated as safety issue: Yes ]
    The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates the degree to which the severity of the subject's depressive illness has improved or worsened compared to baseline severity.


Enrollment: 10
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Magnetic Stimulation
Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Device: Transcranial Magnetic Stimulation
Other Name: NeuroStar

Detailed Description:

This study aims to:

  1. Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
  2. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.
  3. Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
  • Pretreatment CDRS-R Raw score ≥ 40
  • Age is at least 13 and less than 19 years
  • Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):

    • Celexa (citalopram hydrobromide) - 10 to 60mg
    • Cymbalta (duloxetine) - 40mg to 120mg
    • Desyrel (trazodone HCl) - 12.5mg to 150mg
    • Effexor (venlafaxine HCl) - 37.5mg to 300mg
    • Luvox (fluvoxamine maleate) - 25mg to 200mg
    • Lexapro (escitalopram oxalate) - 10mg to 40mg
    • Paxil (paroxetine HCl) - 10mg to 50mg
    • Pristiq (desvenlafaxine) - 50mg to 100mg
    • Prozac (fluoxetine HCl) - 10mg to 80mg
    • Remeron (mirtazapine) - 7.5mg to 45mg
    • Zoloft (sertraline HCl) - 25mg to 200mg
  • Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester
  • Willing to provide informed assent (adolescent) and informed consent (family)

Exclusion Criteria:

  • Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
  • Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
  • Contraindication to MRI
  • Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
  • History of schizophrenia, schizoaffective disorder, other [non mood disorder] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
  • History of autoimmune, endocrine, viral, or vascular disorder.
  • Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
  • Active suicidal intent or plan, or history of attempt within the past 6 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502033

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Paul E. Croarkin
Investigators
Principal Investigator: Paul E Croarkin, DO Mayo Clinic
  More Information

Publications:
Responsible Party: Paul E. Croarkin, Assistant Professor of Child and Adolescent Psychiatry, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01502033     History of Changes
Other Study ID Numbers: 11-004500
Study First Received: December 27, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Adolescent Depression
Transcranial Magnetic Stimulation

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

ClinicalTrials.gov processed this record on September 16, 2014