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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: April 20, 2016
Last verified: April 2016
Results First Received: August 6, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Device: Transcranial Magnetic Stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 participants recruited(and enrolled) from the Mayo Clinic Child and Adolescent Mood Disorders Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were maintained on stable dosage of antidepressant medication for 4 weeks prior to enrollment and rTMS treatment.

Reporting Groups
  Description
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.

Transcranial Magnetic Stimulation


Participant Flow:   Overall Study
    Transcranial Magnetic Stimulation
STARTED   10 [1] 
COMPLETED   7 [2] 
NOT COMPLETED   3 
1 participant had scalp discomfort                1 
1 participant had worsening depression                1 
1 participant went back to school                1 
[1] Milestone (10 participants) met.
[2] Milestone (10 participants) met



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Transcranial Magnetic Stimulation


Baseline Measures
   Transcranial Magnetic Stimulation 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   10 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.9  (1.1) 
Gender 
[Units: Participants]
 
Female   4 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Children's Depression Rating Scale Revised [1] 
[Units: Units on a scale]
Median (Standard Deviation)
 62.9  (8.2) 
[1]

Range of total score is 17-113 Total score of 40 or higher indicates moderate to severe depression (higher scores indicate increased severity of depressive symptoms).

A score below 40 indicates mild or minimal depressive symptoms.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   The Clinical Global Impression - Improvement (CGI-I)   [ Time Frame: Within 5 days of 30 treatments or after last treatment in case of early withdrawal ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Please note that clinical results must be interpreted with caution due to small sample size and study design.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Paul Croarkin
Organization: Mayo Clinic
phone: (507) 293-2557
e-mail: croarkin.paul@mayo.edu


Publications:

Responsible Party: Paul E. Croarkin, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01502033     History of Changes
Other Study ID Numbers: 11-004500
Study First Received: December 27, 2011
Results First Received: August 6, 2015
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration