Intensive Accelerated Theta Burst Stimulation in Treatment of Patients With Bipolar Depression and Suicidality
Bipolar Depression
About this trial
This is an interventional treatment trial for Bipolar Depression
Eligibility 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
Sites / Locations
- Zagazig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Left unilateral aTBS
Sequential bilateral aTBS
Participants who are randomly assigned to this group will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 90% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses).
Participants who are randomly assigned to this group will receive ten sessions daily for five consecutive days for a total of fifty sessions. During each session continuous theta burst stimulation (cTBS) in which (1800 pulses) are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDLPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDLPFC) with using beam method for target localization. Stimulation was at 90% of resting motor threshold.