Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Suicide and Depression
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medhat M Bassiony, Professor; Phone Number: +201005334253; Email: mbassiony@hotmail.com
• Study Contact Backup: Name: Alaa E Zayed, Ass.Lecturer; Phone Number: +201116277409; Email: alaaelsayedzayed@gmail.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Zagazig University
    • Principal Investigator: Medhat M Bassiony, Professor
    • Sub-Investigator: Usama M Youssef, Professor
    • Sub-Investigator: Ghada M Salah El-Deen, Professor
    • Sub-Investigator: Hayam M El-Gohary, Professor
    • Sub-Investigator: Alaa E Zayed, Ass.Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Major depressive episode as a part of MDD or bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I). (First & Gibbon.,2004 ).
• Meeting the severe depression cutoff for MADRS (>/=35) at baseline visit.
• Meeting the severe depression cutoff for BDI-II (>/=30) at baseline visit.
• Presence of suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS)
• Adults (Age 19 years or older )
• Right handedness
• Both genders
• Able to provide informed consent to participate in the study
• Participants were required to have been taking a stable pharmacological regimen for 2 weeks before screening.
• Pass the TMS adult safety screening (TASS) questionnaire

Exclusion Criteria

• Current substance use disorder during the past 3 months
• Current psychotic disorder or symptoms
• Presence of dementia
• Presence of major medical illness, for example metastatic cancer, end stage renal disease
• Inability to verify contact information.
• Presence of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes
• Conductive, ferromagnetic or other magnetic sensitive metals that are implanted or are non-removable within 30 cm treatment coil (around the head)
• Presence of hypomanic symptoms (score on Young Mania Rating Scale (YMRS) greater than 12)
• Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
• Using lorazepam greater than 2 mg daily (or equivalent) due to the potential to limit rTMS efficacy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unipolar depressed patients with suicidality; The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses).	Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark); TMS Therapy System with Theta Burst Stimulation
Active Comparator: Bipolar depressed patients with suicidality; The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses).	Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark); TMS Therapy System with Theta Burst Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS)	The SI severity scale is composed of five yes=no questions of increasingly severe suicidal thoughts: a wish to be dead (1), non-specific suicidal thoughts (2), suicidal thoughts with a method (3), suicidal intent without specific plan (4), and suicidal intent with specific plan (5). This scale was scored from 0 to 5 according to the most severe suicidal ideation endorsed. Higher scores mean worse outcome. Suicidal behaviors were assessed dichotomously (yes=no) and include actual suicide attempts, interrupted suicide attempts, aborted suicide attempts, other preparatory acts (e.g., collecting pills, writing suicide note), and non-suicidal self-injury (NSSI).	Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month, 9 month and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score	The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.	Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month ,9 months and 12 month

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Medhat M Bassiony, Professor, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Depression; Suicide
• Other Study ID Numbers: ZU-IRB #9697

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No