Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients

Suicide and Depression Clinical Trial

Official title: Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Introduction:

Depression is the leading cause of disability worldwide and is associated with increased suicide risk, morbidity and mortality.(Sousa et al .,2022).

In severe cases, depression can result in suicide and approximately 800,000 suicides occur each year (Lepine et al.,2011). 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 al.,2019).

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 ;

Related Conditions & MeSH terms

• Depression
• Suicide
• Suicide and Depression

• NCT number: NCT06289842
• Study type: Interventional
• Source: Zagazig University
• Contact: Medhat M Bassiony, Professor
• Phone: +201005334253
• Email: mbassiony@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Completion date: January 2026