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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Zagazig University
RECRUITING
Zagazig
Contact Information
Primary
Medhat M Bassiony, Professor
mbassiony@hotmail.com
+201005334253
Backup
Alaa E Zayed, Ass.Lecturer
alaaelsayedzayed@gmail.com
+201116277409
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 34
Treatments
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).
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).
Related Therapeutic Areas
Sponsors
Leads: Zagazig University

This content was sourced from clinicaltrials.gov