Cortical Excitability and Inhibition in MDD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01718730
First received: October 29, 2012
Last updated: September 8, 2014
Last verified: September 2014

October 29, 2012
September 8, 2014
October 2012
August 2017   (final data collection date for primary outcome measure)
Cortical Excitability and Inhibition at Motor Cortex [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Motor Threshold (MT) is a single-pulse TMS measure of cortical excitability. A higher MT indicates decreased cortical excitability. Intracortical Facilitation (ICF) is a paired-pulse TMS measure of cortical excitability. A higher ICF indicates increased cortical excitability. Cortical Silent Period (CSP) is a single-pulse TMS measure of cortical inhibition. Longer CSP durations indicate greater cortical inhibition. Intracortical Inhibition (ICI) is a paired pulse TMS measure of cortical inhibition. A lower ICI indicates increased cortical inhibition, and a higher ICI indicates decreased cortical inhibition.
Same as current
Complete list of historical versions of study NCT01718730 on ClinicalTrials.gov Archive Site
Glutamate Concentrations in the Motor Cortex and Anterior Cingulate Cortex [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Glutamate concentrations will be measured with proton magnetic resonance imaging at 3T.
Same as current
Not Provided
Not Provided
 
Cortical Excitability and Inhibition in MDD
Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder

The purpose of this study is to learn if measures of brain activity are different in children and adolescents with depression who are in different stages of treatment. This is important because it may identify a biological marker for depression that could one day be used to identify depressed children who would benefit from certain treatments (medications for example), or to monitor how well treatments are working. Brain activity measures(known as cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can make parts of the brain work without putting any wires or chemicals into the body. Measurements will take place over one 3-hour visit. This study does not provide any form of treatment.

*There is an optional portion of the study that uses a brain scan to gather measures of brain structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.

This study is focused on understanding the neurophysiology of major depressive disorder (MDD), and the impact of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents. This is a cross-sectional study which will utilize single and paired-pulse transcranial magnetic stimulation (TMS) to collect measures of glutamatergic cortical excitability (the motor threshold and intracortical facilitation), and GABAergic cortical inhibition (the cortical silent period and intracortical inhibition) of the motor cortex in chilren and adolescents in various disease states of MDD. The optional proton magnetic resonance spectroscopy and imaging scans (MRS/MRI) at 3 Tesla (3T) will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.

This is a biomarker study (MRI/MRS and TMS neurophysiology measures); treatment is not provided in any form. This study will not utilize Repetitive Transcranial Magnetic Stimulation (rTMS).

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

This protocol will plan to screen depressed children and adolescents who are seeking treatment at Mayo Clinic in Rochester, MN, using strict inclusion and exclusion criteria. These adolescents will represent gender and minority distribution consistent with the Rochester metro/rural area demographic distribution. This study will be inclusive of all races, genders, and socioeconomic classes.

  • Major Depressive Disorder, Recurrent, Mild
  • Depressive Disorder, Major
  • Device: Transcranial Magnetic Stimulation (TMS)
    Single and paired-pulse TMS applied to the motor cortex will collect measures of cortical excitability and inhibition.
    Other Name: Device: Magstim Model 200
  • Device: Magnetic Resonance Spectroscopy and Imaging
    MRS/MRI Scans will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.
    Other Name: MRS/MRI
  • Mild depression
    Subjects with mild, but clinically significant depression
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Device: Magnetic Resonance Spectroscopy and Imaging
  • Moderate to Severe MDD
    Subjects with moderate to severe major depressive disorder who have not yet initiated treatment with an SSRI
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Device: Magnetic Resonance Spectroscopy and Imaging
  • MDD with response to SSRI
    Subjects with moderate to severe major depressive disorder that has responded to an SSRI
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Device: Magnetic Resonance Spectroscopy and Imaging
  • MDD without response to SSRI
    Subjects with moderate to severe major depressive disorder which has not responded to treatment with an SSRI
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Device: Magnetic Resonance Spectroscopy and Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2017
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adolescents from the ages of 13 to 21, male or female.
  • Subjects with MDD (groups 2, 3, and 4):
  • Must have a Children's Depression Rating Scale, Revised (CDRS-R) score of 40 or higher
  • Must have a Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher.
  • Group 1: (50 subjects): Subjects who have mild (CDRS-R score < 40) but clinically significant depression.
  • Group 2: (50 subjects): Subjects with moderate to severe MDD who have not yet initiated treatment with an SSRI.
  • Group 3: (50 subjects): Subjects with moderate to severe MDD that has responded to treatment with an SSRI.
  • Group 4: (50 subjects): Subjects with moderate to severe MDD which has not responded to treatment with an SSRI.
  • Capable of providing informed assent (consent if age 18) in addition to consent by parent or guardian.
  • Subjects and at least 1 parent must be fluent in English.

Exclusion Criteria:

  • Primary Axis I or II disorder other than MDD.
  • Unprovoked seizure history, seizure disorder, history of febrile seizures, family history of epilepsy.
  • Any significant findings on the TMS Adult Safety Screen (TASS) or contraindications to MRI/MRS
  • Subjects who are judged by the Principal Investigator to be at imminent risk for self harm or suicide as indicated by interview or C-SSRS.
  • Pregnancy or suspected pregnancy in females.
  • Metal in the head (except the mouth*), implanted medication pumps, cardiac pacemaker.

    * Subjects with braces will be excluded from MRI/MRS portion of study only

  • Prior brain surgery.
  • Risk for increased intracranial pressure such as a brain tumor.
  • Any unstable medical condition.
Both
13 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01718730
12-000335
No
Paul E. Croarkin, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Paul E Croarkin, D.O. Mayo Clinic
Mayo Clinic
September 2014

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