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Completed

NCT Number: NCT01502033

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

This study aims to:

  • Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
  • 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.
  • Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment

Other names: NeuroStar

Primary outcomes

  1. Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

    Time frame: 5 days of Treatment 30 or Last Treatment

    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 outcomes

  1. 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

    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. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).

  2. The Clinical Global Impression - Improvement (CGI-I)

    Time frame: Within 5 days of 30 treatments or after last treatment in case of early withdrawal

    The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).

Sponsors and collaborators

Lead sponsor

Paul E. Croarkin

Other

Registry information

Official study title

An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2011
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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