Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05798143
Status:
RECRUITING
Last Update Posted:
2023-04-04
First Post:
2023-03-03
Brief Title:
Translational Biomarkers in Accelerated Neuromodulation for Treatment-resistant Depression
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Developing Translational Biomarkers to Predict Clinical Response in Treatment-resistant Depression Towards a Personalized Plasticity-enhancing Accelerated Neuromodulation
Status:
RECRUITING
Status Verified Date:
2023-03
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:
ReModula
Brief Summary:
Background 30-50 of patients with Major Depressive Disorder MDD do not respond adequately despite two or more antidepressant treatments with proper dosage and timing of administration configuring a condition of Treatment-Resistant Depression TRD Repetitive Transcranial Magnetic Stimulation rTMS is a neuromodulation technique that uses a magnetic field to stimulate focal cortical brain regions and it has been approved by the FDA for the treatment of TRD Accelerated rTMS arTMS protocols involve multiple daily sessions of rTMS and they have been shown to be equally effective and safe compared to rTMS protocols with reduced administration time and potentially faster antidepressant efficacy
Objectives The main aim of this study is to identify MDD endophenotypesbiotypes predictive of response to accelerated treatment of rTMS to better characterize the clinical correlates of response in patients with TRD
Eligibility Subjects between 18 and 65 years suffering from TRD in stable psychopharmacological treatment for at least one month
Design This clinical trial includes three phases 1 a screening phase a rTMS continued treatment phase and a follow-up
In order to be enrolled participants will be screened with
Medical history to assess the existence of the inclusion criteria and exclude any medical conditions that could contraindicate treatment with arTMS
Questionnaires
After being enrolled baseline data will be collected In particular participants will be administered
Questionnaires
Functional MRI
Cognitive tasks
Eye examination with Electroretinography ERG
Blood sampling
Salivary cortisol sampling
Repetitive TMS will be delivered during 5 outpatient treatment days 4 timesdie
After treatment patients will be contacted by telephone on a weekly basis for the first 3 weeks to carry out an assessment of the clinical condition
A follow-up visit in the clinic will be carried out after 21 days from the last stimulation Friday with the administration of psychometric scales
Blood samples will be taken on the first day of stimulation and the day after the last stimulation
Salivary cortisol sampling will be taken before the start of the stimulation protocol after the first stimulation day and immediately after the last stimulation session foreseen by the protocol
fMRI will be performed during baseline and at the end of treatment ERG will be performed before the start of the stimulation protocol after the first stimulation and immediately after the last stimulation session foreseen by the protocol Patients will undergo ERG again during the follow-up visit at 21 days
Treatment includes
rTMS A brief electrical current passes through the coil placed on the head At each day participants will receive four rTMS sessions 36 min with a 55 min interval between sessions
MRIs Patients will undergo two MRI sessions lasting 45 min Blood pressure and respiratory rate will be recorded before the examination During fMRI patients will be asked to perform tasks
Eye examination with Electroretinography ERG
Blood and salivary sampling
Screening tests and questionnaires
Objectives The main aim of this study is to identify MDD endophenotypesbiotypes predictive of response to accelerated treatment of rTMS to better characterize the clinical correlates of response in patients with TRD
Eligibility Subjects between 18 and 65 years suffering from TRD in stable psychopharmacological treatment for at least one month
Design This clinical trial includes three phases 1 a screening phase a rTMS continued treatment phase and a follow-up
In order to be enrolled participants will be screened with
Medical history to assess the existence of the inclusion criteria and exclude any medical conditions that could contraindicate treatment with arTMS
Questionnaires
After being enrolled baseline data will be collected In particular participants will be administered
Questionnaires
Functional MRI
Cognitive tasks
Eye examination with Electroretinography ERG
Blood sampling
Salivary cortisol sampling
Repetitive TMS will be delivered during 5 outpatient treatment days 4 timesdie
After treatment patients will be contacted by telephone on a weekly basis for the first 3 weeks to carry out an assessment of the clinical condition
A follow-up visit in the clinic will be carried out after 21 days from the last stimulation Friday with the administration of psychometric scales
Blood samples will be taken on the first day of stimulation and the day after the last stimulation
Salivary cortisol sampling will be taken before the start of the stimulation protocol after the first stimulation day and immediately after the last stimulation session foreseen by the protocol
fMRI will be performed during baseline and at the end of treatment ERG will be performed before the start of the stimulation protocol after the first stimulation and immediately after the last stimulation session foreseen by the protocol Patients will undergo ERG again during the follow-up visit at 21 days
Treatment includes
rTMS A brief electrical current passes through the coil placed on the head At each day participants will receive four rTMS sessions 36 min with a 55 min interval between sessions
MRIs Patients will undergo two MRI sessions lasting 45 min Blood pressure and respiratory rate will be recorded before the examination During fMRI patients will be asked to perform tasks
Eye examination with Electroretinography ERG
Blood and salivary sampling
Screening tests and questionnaires
Detailed Description:
The main aim of the study is to identify MDD endophenotypesbiotypes predictive of response to accelerated treatment of rTMS to consolidate the use of a cost-effective protocol and to better characterize the clinical correlates of response in patients with TRD In addition the present study proposes the following secondary objectives A identification of applicable and reliable peripheral biomarkers related to endophenotypesbiotypes exportable in clinical practice to predict response to treatment B evaluation of potential synergistic additive or antagonistic effects of MDD pharmacotherapies when used in combination with neuromodulation interventionsThe study includes 3 psychiatric assessments with psychometric testing T0 enrollment T1 day 6 T2 week 3 follow-up At T0 enrollment the Researcher will fully inform the patient about the study obtaining the patients informed consent to participate in the study and will determine the patients eligibility Patients will also undergo a battery of cognitive tasks aimed at measuring any changes caused by the neuromodulatory action of arTMS During T1 day 6 and T2 3 weeks the patient will again undergo the tests and neurocognitive evaluations arTMS protocol involves 20 rTMS sessions 4daily for 5 consecutive days each session lasts 35 min with an interval of 55 min Coil is placed on the left dorsolateral prefrontal cortex LDLPFC trains have a frequency of 10 Hz and a intensity of 120 of the individual resting motor threshold
To investigate the possible effects of arTMS on brain connectivity patients will undergo a functional neuroimaging study based on fMRI on T0 and T1 MDD biomarkers measurable by ERG could represent a valid aid in the personalization of treatments ERG will be performed before the start of the stimulation protocol T0 after the first stimulation and immediately after the last stimulation session foreseen by the protocol Patients will undergo ERG again during the follow-up visit at 21 days T2 Blood samples will be taken on the first day of stimulation T0 and the day after the last stimulation to identify reliable peripheral biomarkers related to endophenotypesbiotypes exportable in clinical practice to predict response to treatment Salivary cortisol sampling will be taken before the start of the stimulation protocol T0 after the first stimulation day and immediately after the last stimulation session foreseen by the protocol Some variations in neuroendocrine biomarkers such as cortisol seem to be predictive of response to arTMS treatment The analysis of the neuroimaging ERG and peripheral data will lead to identify MDD endophenotypesbiotypes predictive of response to accelerated treatment of arTMS
To investigate the possible effects of arTMS on brain connectivity patients will undergo a functional neuroimaging study based on fMRI on T0 and T1 MDD biomarkers measurable by ERG could represent a valid aid in the personalization of treatments ERG will be performed before the start of the stimulation protocol T0 after the first stimulation and immediately after the last stimulation session foreseen by the protocol Patients will undergo ERG again during the follow-up visit at 21 days T2 Blood samples will be taken on the first day of stimulation T0 and the day after the last stimulation to identify reliable peripheral biomarkers related to endophenotypesbiotypes exportable in clinical practice to predict response to treatment Salivary cortisol sampling will be taken before the start of the stimulation protocol T0 after the first stimulation day and immediately after the last stimulation session foreseen by the protocol Some variations in neuroendocrine biomarkers such as cortisol seem to be predictive of response to arTMS treatment The analysis of the neuroimaging ERG and peripheral data will lead to identify MDD endophenotypesbiotypes predictive of response to accelerated treatment of arTMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None