Clinical trial · Observational
Cortical Excitability and Inhibition in MDD
Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depressive Disorder, Major | — | UNRESOLVED | — |
| Major Depressive Disorder, Recurrent, Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Spectroscopy and Imaging | Device | — | UNRESOLVED |
| Transcranial Magnetic Stimulation (TMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Mild depression
- description
- Subjects with mild, but clinically significant depression
- interventionNames
- Device: Transcranial Magnetic Stimulation (TMS)
- Device: Magnetic Resonance Spectroscopy and Imaging
- label
- Moderate to Severe MDD
- description
- Subjects with moderate to severe major depressive disorder who have not yet initiated treatment with an SSRI
- interventionNames
- Device: Transcranial Magnetic Stimulation (TMS)
- Device: Magnetic Resonance Spectroscopy and Imaging
- label
- MDD with response to SSRI
- description
- Subjects with moderate to severe major depressive disorder that has responded to an SSRI
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCroarkin 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 24360599