We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01804270
Recruitment Status : Terminated (Study & IDE was converted to Industry held, as opposed to initial investigator held.)
First Posted : March 5, 2013
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This research proposal aims to better understand the neurobiology of depression in adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically impact brain function and mood. This study will be the first to use a randomized, double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed adolescents. This approach will allow for the validation of rTMS treatment outcomes in the depressed adolescent population in a scientifically rigorous manner. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Repetitive transcranial magnetic stimulation (rTMS) Not Applicable

Detailed Description:

Part 1 of the study aims to:

  • Evaluate the antidepressant effects of daily, active rTMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode.

  • Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase.

    • Define regional specificity [anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites(i.e. glutamate and glutamine) in adolescent depression.
    • Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents
Actual Study Start Date : April 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Part 1 Active
Blinded, active repetitive transcranial magnetic stimulation
 Device: Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 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.
Other Name: NeuroStar XPLOR
Sham Comparator: Part 1 Sham
Blinded, sham repetitive transcranial magnetic stimulation
 Device: Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 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.
Other Name: NeuroStar XPLOR


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal) [ Time Frame: Within 5 days after 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.

  2. Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal) [ Time Frame: Within 5 days after 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 the severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.

  3. Mean Clinical Global Impression - Improvement (CGI-I) Score Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal) [ Time Frame: Within 5 days after Treatment 30 or Last Treatment ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 12 and less than 22 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
    • Savella (milnacipran HCl) - 25mg to 200mg
    • Zoloft (sertraline HCl) - 25mg to 200mg
  • Subjects able to attend at least 31 study visits at study site.
  • 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01804270


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Paul E. Croarkin
Investigators
Layout table for investigator information
Principal Investigator: Paul E Croarkin, DO Mayo Clinic
Principal Investigator: Mark A George, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Paul E. Croarkin, Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] October 10, 2014

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Paul E. Croarkin, Assistant Professor of Child and Adolescent Psychiatry, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01804270    
Other Study ID Numbers: 12-003248 Part 1
First Posted: March 5, 2013    Key Record Dates
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Paul E. Croarkin, Mayo Clinic:
Teen
Adolescent
Depression
Transcranial Magnetic Stimulation
TMS
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders