Accelerated theta burst stimulation for reducing suicidality in depressed patients

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

This study is testing a new type of brain stimulation to see if it can help reduce suicidal thoughts in people with severe depression.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Zagazig University (other gov)
• Locations: 1 site (Zagazig)
• Trial ID: NCT06289842 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of accelerated theta burst stimulation (TBS) in reducing suicidal ideation among patients suffering from unipolar and bipolar depression. It aims to address the urgent need for rapid interventions in severe depression cases where traditional treatments may not act quickly enough. Participants will undergo noninvasive transcranial magnetic stimulation using the MagPro R30 device, with eligibility criteria focusing on severe depressive symptoms and confirmed suicidal ideation. The study seeks to provide a novel approach to treating suicidality in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with a diagnosis of major depressive episode or bipolar disorder, experiencing severe depression and suicidal ideation.

Not a fit: Patients with current substance use disorders, psychotic disorders, or major medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce suicidal thoughts and behaviors in patients with severe depression.

How similar studies have performed: While there is growing evidence supporting the use of TBS in treating depression, the specific focus on suicidality as a primary outcome is still relatively novel.

Eligibility criteria

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

Where this trial is running

Zagazig

• Zagazig University — Zagazig, Egypt (RECRUITING)

Study contacts

• Principal investigator: Medhat M Bassiony, Professor — Zagazig University
• Study coordinator: Medhat M Bassiony, Professor

Conditions: Suicide and Depression