Suicide and Depression Clinical Trial
Official title:
Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression
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
Status | Recruiting |
Enrollment | 34 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig University | Zagazig |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 , 6 month, 9 month and 12 month | |
Secondary | Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score | The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month ,9 months and 12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04592809 -
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
|
Phase 3 | |
Recruiting |
NCT05748730 -
Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention
|
N/A | |
Completed |
NCT04275908 -
Classification and Assessment of Mental Health Performance Using Schematics
|
||
Completed |
NCT03633825 -
Brief Online Help-seeking Barrier Reduction Intervention
|
N/A | |
Recruiting |
NCT04783506 -
Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents
|
||
Recruiting |
NCT03565562 -
Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
|
N/A |