CompletedNot Applicable

Cortical Excitability and Inhibition in MDD

United States23 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range

13 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortical Excitability and Inhibition at Motor Cortex

Timeframe: Baseline

Trial details

NCT IDNCT01718730

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08

View on ClinicalTrials.gov More Major Depressive Disorder, Recurrent, Mild trials