Intensive Accelerated Theta Burst Stimulation in Treatment of Patients With Bipolar Depression and Suicidality

NCT05939115 | Unknown DMC

• 1 other identifier: 9697
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the efficacy of left unilateral versus bilateral accelerated Theta Burst Stimulation (TBS) in suicidal reduction and in reduction of severity of depressive symptoms in patients with bipolar depression.

Conditions

Bipolar 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 and 6 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 and 6 month.

Study Arms (2)

Left unilateral aTBS

ACTIVE COMPARATOR

Participants who are randomly assigned to this group 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 90% 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)

Sequential bilateral aTBS

ACTIVE COMPARATOR

Participants who are randomly assigned to this group will receive ten sessions daily for five consecutive days for a total of fifty sessions. During each session continuous theta burst stimulation (cTBS) in which (1800 pulses) are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDLPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDLPFC) with using beam method for target localization. Stimulation was at 90% of resting motor threshold.

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

Left unilateral aTBS; Sequential bilateral aTBS

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 bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
• Meet the threshold on the total MADRS score of \>/=35 at baseline visit (severe)
• Meet the threshold on the total BDI-II score of \>/=30 at baseline visit (severe)
• Ongoing suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS) , score \>/=3 (moderate to high risk)
• Age 19 years or older (Adults, Older Adults)
• 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 that had to include a mood stabilizer (lithium \>0.6 mEq/L or valproate \>350 mM/L), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic. For participants with BD type II, lamotrigine monotherapy was acceptable if the dose was greater than 100 mg daily
• Pass the TMS adult safety screening (TASS) questionnaire

You may not qualify if:

• Any psychotic disorder or current active psychotic symptoms
• No dementia or other major neurological disorders
• No major medical illness, for example metastatic cancer, end stage renal disease
• Not able to verify contact information. Participants must be able to follow through with the study \& must have verified contact information and at least one verified contact
• Any history 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)
• Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment)
• Rapid cycling Bipolar illness (patients with \> 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania)
• Non response to ECT in current episode.
• Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
• Are currently (or in the last 4 weeks) taking 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, 7120730, Egypt

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Medhat M Bassiony, Professor

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Usama M Youssef, Professor

  Zagazig University

  STUDY DIRECTOR

• Ghada M Salah El-Deen, Professor

  Zagazig University

  STUDY DIRECTOR

• Hayam M El-Gohary, Professor

  Zagazig University

  STUDY DIRECTOR

• Alaa E Zayed, Ass.Lecturer

  Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Medhat M Bassiony, Professor

CONTACT

+2001005334253; mbassiony@hotmail.com

Alaa E Zayed, Ass.Lecturer

CONTACT

+2001116277409; 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: June 24, 2023
• First Posted: July 11, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)