Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05652465
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-12-14
Brief Title:
Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open Trial of Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Major depressive disorder MDD is one of the most impairing medical conditions in the world Medication and some kinds of talk therapy are standard treatments for teens with MDD but these do not work well for everyone Transcranial magnetic stimulation TMS has been approved to treat MDD in adults TMS might help adolescents too
Objective
To test TMS combined with cognitive behavioral therapy CBT in teens with MDD
Eligibility
People aged 13 to 17 years with MDD that has not responded to treatment
Design
Participants will be screened They will have a physical exam and psychiatric evaluation They will have an MRI scan and a test of their heart function They will enroll in 2 NIH protocols 01-M-0254 and 18-M-0037
For 2 to 6 weeks participants will have weekly CBT a kind of talk therapy They will taper off of their psychiatric medicines
For 2 weeks participants will come to the clinic every weekday They will receive 3 or 4 sessions of TMS on each of those days A wire coil will be held on their scalp A brief electrical current in the coil creates a magnetic pulse that affects brain activity They will receive 30 TMS pulses in 10-second bursts these will be repeated 60 times in each 15-minute session Participants may hear a click and feel a pulling sensation under the coil They may feel their muscles twitch Each day they will have tests of concentration thinking and memory Some may have a 3rd week of TMS
Participants will remain in the study for 5 more weeks They will begin taking their medications again
Major depressive disorder MDD is one of the most impairing medical conditions in the world Medication and some kinds of talk therapy are standard treatments for teens with MDD but these do not work well for everyone Transcranial magnetic stimulation TMS has been approved to treat MDD in adults TMS might help adolescents too
Objective
To test TMS combined with cognitive behavioral therapy CBT in teens with MDD
Eligibility
People aged 13 to 17 years with MDD that has not responded to treatment
Design
Participants will be screened They will have a physical exam and psychiatric evaluation They will have an MRI scan and a test of their heart function They will enroll in 2 NIH protocols 01-M-0254 and 18-M-0037
For 2 to 6 weeks participants will have weekly CBT a kind of talk therapy They will taper off of their psychiatric medicines
For 2 weeks participants will come to the clinic every weekday They will receive 3 or 4 sessions of TMS on each of those days A wire coil will be held on their scalp A brief electrical current in the coil creates a magnetic pulse that affects brain activity They will receive 30 TMS pulses in 10-second bursts these will be repeated 60 times in each 15-minute session Participants may hear a click and feel a pulling sensation under the coil They may feel their muscles twitch Each day they will have tests of concentration thinking and memory Some may have a 3rd week of TMS
Participants will remain in the study for 5 more weeks They will begin taking their medications again
Detailed Description:
Study Description
This is a safety and pilot efficacy study of open neuronavigated intermittent theta burst stimulation iTBS a form of repetitive transcranial magnetic stimulation rTMS in medication-free youth with treatment-resistant major depression The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents
Objectives
The study has two objectives 1 To evaluate safety feasibility and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression 2 To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression
Endpoints
Primary Endpoints
Children s Depression Rating Scale CDRS rates of treatment completion and adverse events on standard rating scales
Secondary Endpoints
1 Clinical Global Impression Improvement Scale CGI-I
2 Mood and Feelings Questionnaire MFQ
3 Screen for Child Anxiety Related Disorders SCARED
4 Resting state fMRI correlations across brain regions
5 Task-based fMRI activation to cognitive conflict
6 Fractional anisotropy on diffusion tensor imaging
7 Neurochemicals assessed by magnetic resonance spectroscopy
This is a safety and pilot efficacy study of open neuronavigated intermittent theta burst stimulation iTBS a form of repetitive transcranial magnetic stimulation rTMS in medication-free youth with treatment-resistant major depression The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents
Objectives
The study has two objectives 1 To evaluate safety feasibility and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression 2 To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression
Endpoints
Primary Endpoints
Children s Depression Rating Scale CDRS rates of treatment completion and adverse events on standard rating scales
Secondary Endpoints
1 Clinical Global Impression Improvement Scale CGI-I
2 Mood and Feelings Questionnaire MFQ
3 Screen for Child Anxiety Related Disorders SCARED
4 Resting state fMRI correlations across brain regions
5 Task-based fMRI activation to cognitive conflict
6 Fractional anisotropy on diffusion tensor imaging
7 Neurochemicals assessed by magnetic resonance spectroscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000776-M | None | None | None |