Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644833
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
EffectiveTranscranial Magnetic Stimulation TMS vs Treatment as Usual for First-Episode Depression in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Transcranial Magnetic Stimulation TMS Versus Treatment as Usual for First-Episode Depression in Adult Patients An Open-Label Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation TMS compared to Treatment as Usual TAU in adult patients experiencing their first or second episode of unipolar major depressive disorder MDD The primary end point is to determine whether TMS leads to higher rate of remission response and greater reductions in depression severity and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions The trial will also explore the impact of TMS on quality of life and anxiety symptoms Participants will be randomly assigned to either the TMS or TAU group and outcomes will be assessed at multiple time points over a 3-year period The trial will be conducted at Sultan Qaboos University Hospitals Department of Behavioural Medicine in Muscat Oman and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression
Detailed Description:
11 Background and Rationale First-episode depression FED comprises 50 of major depressive disorder MDD cases in the US and contributes 80 of global disability due to mental and substance use disorders Depression significantly impairs social and occupational functioning ranking third among the leading causes of global disease burden for individuals aged 10-65 Untreated FED may progress to chronic depression addiction and increased healthcare costs Given the limitations of current antidepressant treatments there is a growing need for alternative interventions such as transcranial magnetic stimulation TMS TMS is a non-invasive well-accepted therapy with emerging evidence of efficacy for depression but its use in first-episode depression requires further research This trial aims to compare the effectiveness of TMS versus Treatment as Usual TAU for adult FED patients
12 Study Scope This open-label study will follow FED patients 18 years with moderate or severe MDD in an outpatient setting Exclusion criteria include substance abuse psychotic or catatonic features suicidal risk or previous ineffective TMS treatment Pregnant or breastfeeding women can participate with neurologist approval Primary outcomes will measure depression severity and functional impairment assessed at baseline and at four key follow-up points
2 Methodology A randomized controlled trial RCT will assess the comparative effectiveness of TMS and TAU Participants will be randomly assigned to receive either TMS or TAU with depression severity measured by standardized scales such as the Hamilton Depression Rating Scale HAMD-24 and the World Health Organization Disability Assessment Schedule WHO-DAS 20 Baseline data and follow-up assessments will evaluate the impact of treatment on depressive symptoms quality of life and functional outcomes
21 Study Design The study will recruit adult patients experiencing their first episode of MDD Inclusion and exclusion criteria will ensure a homogenous sample Participants will provide written informed consent and undergo baseline assessments before randomization into either the TMS or TAU group TMS will be administered by trained operators using a standardized protocol Follow-up will occur over six months with assessments of depressive symptoms functional outcomes and quality of life at regular intervals
22 Interventions Participants in the TMS group will receive 10 Hz stimulation at 120 motor threshold for 30 minutes per session The TAU group will follow standard pharmacological and psychotherapeutic management Safety measures include constant monitoring during TMS sessions with anxiety management protocols in place
12 Study Scope This open-label study will follow FED patients 18 years with moderate or severe MDD in an outpatient setting Exclusion criteria include substance abuse psychotic or catatonic features suicidal risk or previous ineffective TMS treatment Pregnant or breastfeeding women can participate with neurologist approval Primary outcomes will measure depression severity and functional impairment assessed at baseline and at four key follow-up points
2 Methodology A randomized controlled trial RCT will assess the comparative effectiveness of TMS and TAU Participants will be randomly assigned to receive either TMS or TAU with depression severity measured by standardized scales such as the Hamilton Depression Rating Scale HAMD-24 and the World Health Organization Disability Assessment Schedule WHO-DAS 20 Baseline data and follow-up assessments will evaluate the impact of treatment on depressive symptoms quality of life and functional outcomes
21 Study Design The study will recruit adult patients experiencing their first episode of MDD Inclusion and exclusion criteria will ensure a homogenous sample Participants will provide written informed consent and undergo baseline assessments before randomization into either the TMS or TAU group TMS will be administered by trained operators using a standardized protocol Follow-up will occur over six months with assessments of depressive symptoms functional outcomes and quality of life at regular intervals
22 Interventions Participants in the TMS group will receive 10 Hz stimulation at 120 motor threshold for 30 minutes per session The TAU group will follow standard pharmacological and psychotherapeutic management Safety measures include constant monitoring during TMS sessions with anxiety management protocols in place
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None