Comparing two methods of brain stimulation for bipolar depression and suicidality
Efficacy of Unilateral Versus Bilateral Accelerated Theta Burst Stimulation in Treatment of Patients With Bipolar Depression and Suicidality
This study is testing two different brain stimulation methods to see which one helps reduce depression and suicidal thoughts in people with bipolar depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT05939115 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different approaches to accelerated Theta Burst Stimulation (TBS) in reducing suicidality and depressive symptoms in patients with bipolar depression. Participants will receive either left unilateral or bilateral TBS using a specialized transcranial magnetic stimulation device. The study will assess changes in suicidal ideation and severity of depressive symptoms through established clinical scales. The goal is to determine which method is more effective in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with a diagnosis of bipolar disorder experiencing severe depressive episodes and ongoing suicidal ideation.
Not a fit: Patients who do not have bipolar disorder or those who are not experiencing severe depressive symptoms or suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from bipolar depression and suicidality.
How similar studies have performed: While there is limited evidence for the efficacy of rTMS in bipolar depression, previous studies have shown promising results for similar neurostimulation approaches in treating major depressive disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Major depressive episode as a part of bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) * Meet the threshold on the total MADRS score of \>/=35 at baseline visit (severe) * Meet the threshold on the total BDI-II score of \>/=30 at baseline visit (severe) * Ongoing suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS) , score \>/=3 (moderate to high risk) * Age 19 years or older (Adults, Older Adults) * 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 that had to include a mood stabilizer (lithium \>0.6 mEq/L or valproate \>350 mM/L), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic. For participants with BD type II, lamotrigine monotherapy was acceptable if the dose was greater than 100 mg daily * Pass the TMS adult safety screening (TASS) questionnaire Exclusion Criteria: * No current substance abuse disorder for the past 3 months (previous substance abuse not exclusionary) * Any psychotic disorder or current active psychotic symptoms * No dementia or other major neurological disorders * No major medical illness, for example metastatic cancer, end stage renal disease * Not able to verify contact information. Participants must be able to follow through with the study \& must have verified contact information and at least one verified contact * Pregnancy. While there are no known risks to a fetus this is a new use of TMS, which has not been tested, thus pregnancy is exclusionary * Any history 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) * Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment) * Rapid cycling Bipolar illness (patients with \> 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania) * Non response to ECT in current episode. * Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation) * Are currently (or in the last 4 weeks) taking 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
- Email: mbassiony@hotmail.com
- Phone: +2001005334253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.