Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients

Launched by ZAGAZIG UNIVERSITY · Feb 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called accelerated theta burst stimulation (TBS) to help reduce suicidal thoughts in adults who are experiencing severe depression. The trial is looking for participants aged 19 and older who have been diagnosed with major depressive disorder or bipolar disorder and are currently having significant symptoms, including suicidal thoughts. To qualify, participants must have specific scores indicating severe depression and should be right-handed. They also need to have been on a stable medication plan for at least two weeks prior to joining the study.

Participants in this trial can expect to receive TBS treatment, which is a non-invasive approach that uses magnetic pulses to stimulate the brain. Throughout the study, participants will be closely monitored for their mental health progress. It’s important to know that there are certain conditions that might exclude someone from participating, such as having a current substance use disorder, severe insomnia, or specific neurological issues. This trial aims to provide new insights into how TBS can help those struggling with depression and suicidal thoughts.

Gender

ALL

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