Cortical Excitability and Inhibition in MDD
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 13 - 21 |
| Updated: | 9/30/2018 |
| Start Date: | October 2012 |
| End Date: | August 2019 |
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.
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).
(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).
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.
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Paul E Croarkin, D.O.
Phone: 507-255-5452
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