An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression

This study has been completed.

Study NCT00587639 Information provided by Mayo Clinic

First Received on December 21, 2007. Last Updated on March 8, 2012 History of Changes

Results First Received: July 20, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Depression
Intervention:	Device: rTMS Treatment

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
Subjects were recruited from clinical and community referrals at 3 participating sites. The study took place from May 2007 to October 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Active Treatment	All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)

Participant Flow: Overall Study

	Active Treatment
STARTED	8
COMPLETED	7
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Active Treatment	All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)

Baseline Measures

	Active Treatment
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	8
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	16.5 ± 1.18
Gender [units: participants]
Female	7
Male	1
Region of Enrollment [units: participants]
United States	8

Outcome Measures

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1. Primary:

Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) [ Time Frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) ]

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2. Secondary:

Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: At study visit 30 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
Limitations of the study include its open design, and small number of total participants.

Results Point of Contact:

Name/Title: Dr. Christopher Wall
Organization: Mayo Clinic
phone: 5072843352
e-mail: wall.chris@mayo.edu

Publications of Results:

Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9.

Responsible Party:	Christopher A. Wall, M.D., Mayo Clinic - Rochester
ClinicalTrials.gov Identifier:	NCT00587639 History of Changes
Other Study ID Numbers:	07-000495
Study First Received:	December 21, 2007
Results First Received:	July 20, 2011
Last Updated:	March 8, 2012
Health Authority:	United States: Food and Drug Administration