Transcranial Magnetic Stimulation for Adolescent Depression (TMSAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Frank MacMaster, PhD, University of Calgary
ClinicalTrials.gov Identifier:
NCT01731678
First received: November 3, 2012
Last updated: November 21, 2012
Last verified: November 2012

November 3, 2012
November 21, 2012
November 2012
November 2015   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
A reduction of Hamilton Depression Rating Scale score of 50% is considered positive response
Same as current
Complete list of historical versions of study NCT01731678 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Interim Analysis - rTMS tolerability scale [ Time Frame: After the first 10 patients are completed ] [ Designated as safety issue: Yes ]
    There will be an interim analysis to review safety, tolerability (as measured by our rTMS tolerability scale) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.
  • Interim Analysis - Ham-D [ Time Frame: After the first 10 patients are completed ] [ Designated as safety issue: Yes ]
    There will be an interim analysis to review response (Ham-D) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.
Same as current
 
Transcranial Magnetic Stimulation for Adolescent Depression
Transcranial Magnetic Stimulation for Adolescent Depression

Major depression (or MDD) in adolescents is a major public health problem. MDD affects approximately 15% of adolescents; it is associated with impairment in social, family, and academic functioning, and it is a major risk factor for suicide - a leading cause of death in adolescents . Unfortunately, there is a paucity of treatment options for this age group. Selective serotonin reuptake inhibitors (SSRIs) are the only class of medications approved for treating MDD in adolescents, but rates of remission following treatment with SSRIs are only 30 to 45 percent. Cognitive behavior therapy is associated with similar remission rates and access is limited. Most adolescents will require more than one therapeutic intervention in order to achieve full symptom control. Collectively, there is overwhelming evidence that additional treatment options are urgently needed to improve outcomes for teens with MDD. One novel treatment for adolescent MDD is repetitive transcranial magnetic stimulation (rTMS). Studies in children have been limited (a total of 23 cases). This is surprising given the evidence suggesting younger adult subjects with MDD respond better to rTMS (56% response rate) than older subjects. This limited experience with rTMS for adolescent MDD represents a substantial gap in the knowledge, recently recognized in publications calling for further study of rTMS in adolescent depression. Most importantly, the mechanism of action of rTMS in adolescent MDD is not well understood. The objective of this application is to develop an understanding of the brain alterations associated with the positive clinical changes that occur with rTMS in adolescent MDD. Such knowledge will provide the basis for pursuing rTMS for adolescent MDD as a rational therapeutic technique.

Specific Aim: To compare the effect of rTMS on DLPFC glutamate concentration in adolescent MDD. The investigators hypothesize an increase (normalization to controls) in DLPFC glutamate after three weeks of rTMS. Furthermore, the change in glutamate concentration will correlate with a change in MDD symptoms.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Procedure: Transcranial Magnetic Stimulation
The standardized treatment location will be the left DLPFC. Anatomical T1 images from the pre-intervention MRI will be loaded into our Transcranial Magnetic Stimulation (TMS) lab neuronavigation software (Brainsight2, Rogue Research, Montreal). Following 3D co-registration of the TMS coil with the patient's MRI images and head, the coil will be placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) will consist of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Experimental: Transcranial Magnetic Stimulation
The standardized treatment location will be the left DLPFC. Anatomical T1 images from the pre-intervention MRI will be loaded into our Transcranial Magnetic Stimulation (TMS) lab neuronavigation software (Brainsight2, Rogue Research, Montreal). Following 3D co-registration of the TMS coil with the patient's MRI images and head, the coil will be placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) will consist of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Intervention: Procedure: Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age (12-22 years),
  • MDD failing to respond to at least one SSRI trial (minimum 8 weeks treatment at an adequate dose; determined retrospectively), and
  • informed consent. Healthy controls with no psychiatric history (who do not receive rTMS) will undergo MRI scans to allow for comparison with MDD patients.

Exclusion Criteria:

  • previous seizures or epilepsy,
  • hypertension,
  • additional neurological or psychiatric diagnoses (specifically: bipolar disorder, psychosis, pervasive developmental disorder, eating disorders, and post-traumatic stress disorder).

As 3T MRI will be used, pregnancy is exclusionary.

Both
12 Years to 21 Years
Yes
Contact: Frank P MacMaster, PhD 403-955-2784 fmacmast@ucalgary.ca
Canada
 
NCT01731678
E-24656
No
Frank MacMaster, PhD, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Frank P MacMaster, PhD University of Calgary
University of Calgary
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP