Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289842
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-24
Brief Title:
Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The objective of this study is to investigate efficacy of accelerated theta burst stimulation TBS in suicidal reduction in patients with unipolar and bipolar depression
Detailed Description:
Introduction
Depression is the leading cause of disability worldwide and is associated with increased suicide risk morbidity and mortalitySousa et al 2022
In severe cases depression can result in suicide and approximately 800000 suicides occur each year Lepine et al2011 Rates of completed suicide are also high varying from 10 to 19 Goodwin et al 1990 Lifetime rates of attempted suicide in bipolar depression range 26-29 and 14-16 in unipolar depression disorder Chen et al 1996
The general recommendation to reduce suicide risk is the effective treatment of the underlying depressive disorder with medications and psychosocial interventions Jacobs et al 2010 However there exist several difficulties Neither antidepressants nor psychotherapy work fast enough for reduction of suicidal ideation
Beside pharmacotherapy and psychotherapy brain stimulation methods have gained increasing relevance in the treatment of depression during the last decades Baeken et al2019
Repetitive transcranial magnetic stimulation rTMS therapy is a noninvasive neurostimulation treatment that has been adopted as a first-line treatment for pharmacotherapy-resistant major depressive disorder MDD Milev et al 2016
Despite this growing evidence base supporting iTBS in the treatment of MDD evidence for its efficacy in the treatment of suicidality as a primary outcome in both unipolar and bipolar depressive patients is still lacking
Hypothesis We assume that accelerated TBS is effective in treatment of suicidality as well as depressive symptoms in both unipolar and bipolar patients
Aim This study aims to reduce morbidity and mortality of unipolar and bipolar depressive patients and to improve overall functioning
Objectives
1 To investigate efficacy of accelerated TBS in suicidal reduction as primary outcome in patients with unipolar and bipolar depression
2 To compare efficacy of accelerated TBS in reduction of severity of depressive symptoms in unipolar and bipolar disorder as well as response and remission rates
3 To investigate association between the reduction of suicidality and the reduction of depressive symptoms
Depression is the leading cause of disability worldwide and is associated with increased suicide risk morbidity and mortalitySousa et al 2022
In severe cases depression can result in suicide and approximately 800000 suicides occur each year Lepine et al2011 Rates of completed suicide are also high varying from 10 to 19 Goodwin et al 1990 Lifetime rates of attempted suicide in bipolar depression range 26-29 and 14-16 in unipolar depression disorder Chen et al 1996
The general recommendation to reduce suicide risk is the effective treatment of the underlying depressive disorder with medications and psychosocial interventions Jacobs et al 2010 However there exist several difficulties Neither antidepressants nor psychotherapy work fast enough for reduction of suicidal ideation
Beside pharmacotherapy and psychotherapy brain stimulation methods have gained increasing relevance in the treatment of depression during the last decades Baeken et al2019
Repetitive transcranial magnetic stimulation rTMS therapy is a noninvasive neurostimulation treatment that has been adopted as a first-line treatment for pharmacotherapy-resistant major depressive disorder MDD Milev et al 2016
Despite this growing evidence base supporting iTBS in the treatment of MDD evidence for its efficacy in the treatment of suicidality as a primary outcome in both unipolar and bipolar depressive patients is still lacking
Hypothesis We assume that accelerated TBS is effective in treatment of suicidality as well as depressive symptoms in both unipolar and bipolar patients
Aim This study aims to reduce morbidity and mortality of unipolar and bipolar depressive patients and to improve overall functioning
Objectives
1 To investigate efficacy of accelerated TBS in suicidal reduction as primary outcome in patients with unipolar and bipolar depression
2 To compare efficacy of accelerated TBS in reduction of severity of depressive symptoms in unipolar and bipolar disorder as well as response and remission rates
3 To investigate association between the reduction of suicidality and the reduction of depressive symptoms
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?:
None
Is an FDA AA801 Violation?:
None