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Completed

NCT Number: NCT01718730

Cortical Excitability and Inhibition in MDD

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.

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Key information

Conditions

Major Depressive Disorder, Recurrent, Mild Depressive Disorder Depressive Disorder, Major Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mood Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

Single and paired-pulse TMS applied to the motor cortex will collect measures of cortical excitability and inhibition.

Other names: Device: Magstim Model 200

Magnetic Resonance Spectroscopy and Imaging

Device

MRS/MRI Scans will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.

Other names: MRS/MRI

Primary outcomes

  1. Cortical Excitability and Inhibition at Motor Cortex

    Time frame: Baseline

    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.

Secondary outcomes

  1. Glutamate Concentrations in the Motor Cortex and Anterior Cingulate Cortex

    Time frame: Baseline

    Glutamate concentrations will be measured with proton magnetic resonance imaging at 3T.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Neuronetics

Registry information

Official study title

Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2012
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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