Depressive Disorder, Major Clinical Trial
Official title:
Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder
NCT number | NCT01718730 |
Other study ID # | 12-000335 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | August 2019 |
Verified date | October 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Neuronetics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Glutamate Concentrations in the Motor Cortex and Anterior Cingulate Cortex | Glutamate concentrations will be measured with proton magnetic resonance imaging at 3T. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05988333 -
Psychoeducational Intervention for Families With a Member Affected by Major Depression
|
N/A | |
Completed |
NCT02919501 -
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
|
Phase 2 | |
Completed |
NCT00976560 -
Clinical Study to Test a New Drug to Treat Major Depression
|
Phase 2 | |
Recruiting |
NCT05518149 -
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
|
Phase 3 | |
Not yet recruiting |
NCT06303076 -
Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial
|
Phase 4 | |
Not yet recruiting |
NCT05901571 -
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Suspended |
NCT02546024 -
Predictors of Treatment Response in Late-onset Major Depressive Disorder
|
N/A | |
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01583400 -
Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
|
N/A | |
Completed |
NCT01152996 -
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
|
Phase 3 | |
Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
Completed |
NCT00384033 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT00369343 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00366652 -
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
|
Phase 3 | |
Completed |
NCT00149643 -
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
|
Phase 2 | |
Completed |
NCT00316160 -
Sexual Functioning Study With Antidepressants
|
Phase 4 |