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Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients

RECRUITINGN/ASponsored by Zagazig University
Actively Recruiting
PhaseN/A
SponsorZagazig University
Started2024-02-01
Est. completion2025-01
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06289842

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

Age: 19 Years+Healthy volunteers accepted
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

Conditions2

DepressionSuicide and Depression

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