Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients

NCT06289842 | Recruiting DMC

• 1 other identifier: ZU-IRB #9697
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Suicide and Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score

  Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month ,9 months and 12 month

Study Arms (2)

Unipolar depressed patients with suicidality

ACTIVE COMPARATOR

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)

Bipolar depressed patients with suicidality

ACTIVE COMPARATOR

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)

Interventions

Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) DEVICE

TMS Therapy System with Theta Burst Stimulation

Bipolar depressed patients with suicidality; Unipolar depressed patients with suicidality

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Suicide; Depression

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Medhat M Bassiony, Professor

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhat M Bassiony, Professor

CONTACT

+201005334253; mbassiony@hotmail.com

Alaa E Zayed, Ass.Lecturer

CONTACT

+201116277409; alaaelsayedzayed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 4, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

EG (1)