Cortical Excitability and Inhibition in MDD
1 other identifier
observational
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedOctober 22, 2019
October 1, 2019
6.8 years
October 29, 2012
October 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cortical Excitability and Inhibition at Motor Cortex
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.
Baseline
Secondary Outcomes (1)
Glutamate Concentrations in the Motor Cortex and Anterior Cingulate Cortex
Baseline
Study Arms (4)
Mild depression
Subjects with mild, but clinically significant depression
Moderate to Severe MDD
Subjects with moderate to severe major depressive disorder who have not yet initiated treatment with an SSRI
MDD with response to SSRI
Subjects with moderate to severe major depressive disorder that has responded to an SSRI
MDD without response to SSRI
Subjects with moderate to severe major depressive disorder which has not responded to treatment with an SSRI
Interventions
Single and paired-pulse TMS applied to the motor cortex will collect measures of cortical excitability and inhibition.
MRS/MRI Scans will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Neuroneticscollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Croarkin PE, Nakonezny PA, Husain MM, Port JD, Melton T, Kennard BD, Emslie GJ, Kozel FA, Daskalakis ZJ. Evidence for pretreatment LICI deficits among depressed children and adolescents with nonresponse to fluoxetine. Brain Stimul. 2014 Mar-Apr;7(2):243-51. doi: 10.1016/j.brs.2013.11.006. Epub 2013 Dec 3.
PMID: 24360599DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul E Croarkin, D.O.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 29, 2012
First Posted
October 31, 2012
Study Start
October 1, 2012
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
October 22, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share