Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900271
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-05-10
Brief Title:
Dutch-Depression Outcome Trial Comparing 5 Day Multi Daily Neuronavigated Theta Burst Sessions With 6 Weeks rTMS
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Higher Faster Better Is an Accelerated Intermittent Theta Burst Stimulation Protocol Compared to Standard 10 Hz Repetitive Transcranial Magnetic Stimulation More Cost- Effective in Patients With Treatment-resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DDOTT
Brief Summary:
INTRODUCTION Recent findings from three small studies total n59 suggest that three changes in repetitive Transcranial Magnetic Stimulation rTMS protocols called the Stanford Neuromodulation Therapy SNT protocol contribute to extreme high overall remission of 79 in patients with treatment resistant depression TRD whereas remission using a standard 10 Hz rTMS protocol is 25 The improvement using the SNT protocol is achieved by combining 1 accelerated treatment with multiple sessions per day 2 applying a higher overall pulse dose of stimulation using intermittent Theta Burst Stimulation iTBS and 3 precise targeting of the region in the left dorsolateral prefrontal cortex DLPFC using functional MRI guided neuronavigation
OBJECTIVE To determine if the SNT protocol is more cost- effective compared to standard 10 Hz rTMS in patients with TRD even though the number of pulses given in both protocols is equal ie 90000
STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks
STUDY POPULATION 108 Patients with TRD no response to 2 or more evidence-based treatments
INTERVENTION 50 sessions using the SNT protocol in 5 days The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI
COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks targeting the left DLPFC based on standard measurement procedures of the skull
OUTCOME MEASURES
Remission based on the Hamilton depression rating scale
Cost effectiveness based on healthcare resource use
Quality of life and positive mental health
Tolerability and safety
Relapse
Description of opportunities and difficulties with regard to implementation
SAMPLE SIZE The investigators will enrol 108 patients α005 power is 080 including adjustment for attrition
COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare reduced illness duration and absence from work
TIME SCHEDULE Within 36 months the investigators will recruit and treat 108 patients with TRD each center will recruit 9 patients per year After the last follow-up assessments the investigators will finalise the study within 12 months and report the results
OBJECTIVE To determine if the SNT protocol is more cost- effective compared to standard 10 Hz rTMS in patients with TRD even though the number of pulses given in both protocols is equal ie 90000
STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks
STUDY POPULATION 108 Patients with TRD no response to 2 or more evidence-based treatments
INTERVENTION 50 sessions using the SNT protocol in 5 days The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI
COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks targeting the left DLPFC based on standard measurement procedures of the skull
OUTCOME MEASURES
Remission based on the Hamilton depression rating scale
Cost effectiveness based on healthcare resource use
Quality of life and positive mental health
Tolerability and safety
Relapse
Description of opportunities and difficulties with regard to implementation
SAMPLE SIZE The investigators will enrol 108 patients α005 power is 080 including adjustment for attrition
COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare reduced illness duration and absence from work
TIME SCHEDULE Within 36 months the investigators will recruit and treat 108 patients with TRD each center will recruit 9 patients per year After the last follow-up assessments the investigators will finalise the study within 12 months and report the results
Detailed Description:
Rationale Novel therapies are crucial for patients with unipolar depression since more than 33 of these patients are medication-resistant As a consequence there is a high burden of illness for patients with depression leading to increased suicide rates inability to maintain proper work andor social role functions and reduced quality of life A promising novel treatment strategy is an intensive five-day course of intermittent Theta Burst Stimulation iTBS a form of transcranial magnetic stimulation rTMS which could lead to exceptionally high remission rates 79 in patients with treatment resistant depression However it remains unclear whether this novel treatment strategy is more effective in depressed patients when compared to standard 10Hz rTMS remission 30
Hypothesis 5-day multi daily neuronavigated iTBS sessions developed by Stanford University and coined SNT ie Stanford NeuromdulaTion protocol are more cost- effective than standard 10 Hz rTMS in patients with treatment resistant depression
Objective To determine remission of depression and cost effectiveness using the SNT protocol in patients with treatment resistant depression who did not respond to two or more evidence-based treatments
Study design This study comprises a multicentre two-phase randomized clinical trial Phase 1 comprises a randomized controlled trial In Phase 1 participants will be assigned to one of the two active treatment conditions and will receive either treatment using the SNT protocol 5 days of 10 sessionsday resulting in 50 sessions in total 90000 pulses or standard 10 Hz left sided rTMS provided once daily during 6 weeks 30 sessions in total 90000 pulses Phase 2 comprises three follow-up measurements one at 5 weeks one at 10 weeks and one at 25 weeks after the last treatment with SNT or 10 Hz standard rTMS Finally participants who were allocated to standard 10 Hz rTMS will be offered SNT after the end of the study eg 25 weeks after the last rTMS session Patients allocated to SNT can obtain 10 Hz standard rTMS after SNT has been completed
Study population Adult patients with unipolar depression who did not respond to two or more evidence-based treatments for depression in the current depressive episode aged 18 years and over
Sample size Sample size calculations based on differences in remission suggest that a well-powered trial should consist of 108 patients for a 2-sided test at alpha005 and with power080
Intervention 50 sessions using the SNT protocol in 5 days The subregion of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex sgACC in each participant will be targeted based on patient-specific functional resting state magnetic resonance imaging
Comparison 30 standard daily 10 Hz rTMS sessions in six weeks targeting the left DLPFC based on standard scalp-based measurement procedures
Hypothesis 5-day multi daily neuronavigated iTBS sessions developed by Stanford University and coined SNT ie Stanford NeuromdulaTion protocol are more cost- effective than standard 10 Hz rTMS in patients with treatment resistant depression
Objective To determine remission of depression and cost effectiveness using the SNT protocol in patients with treatment resistant depression who did not respond to two or more evidence-based treatments
Study design This study comprises a multicentre two-phase randomized clinical trial Phase 1 comprises a randomized controlled trial In Phase 1 participants will be assigned to one of the two active treatment conditions and will receive either treatment using the SNT protocol 5 days of 10 sessionsday resulting in 50 sessions in total 90000 pulses or standard 10 Hz left sided rTMS provided once daily during 6 weeks 30 sessions in total 90000 pulses Phase 2 comprises three follow-up measurements one at 5 weeks one at 10 weeks and one at 25 weeks after the last treatment with SNT or 10 Hz standard rTMS Finally participants who were allocated to standard 10 Hz rTMS will be offered SNT after the end of the study eg 25 weeks after the last rTMS session Patients allocated to SNT can obtain 10 Hz standard rTMS after SNT has been completed
Study population Adult patients with unipolar depression who did not respond to two or more evidence-based treatments for depression in the current depressive episode aged 18 years and over
Sample size Sample size calculations based on differences in remission suggest that a well-powered trial should consist of 108 patients for a 2-sided test at alpha005 and with power080
Intervention 50 sessions using the SNT protocol in 5 days The subregion of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex sgACC in each participant will be targeted based on patient-specific functional resting state magnetic resonance imaging
Comparison 30 standard daily 10 Hz rTMS sessions in six weeks targeting the left DLPFC based on standard scalp-based measurement procedures
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