Houston, Texas 77030

  • Bipolar Disorder

Purpose:

The purpose of this study is to determine the effectiveness of MST in bipolar depression and to compare the side effects of magnetic seizure therapy (MST) and electroconvulsive therapy (ECT)


Criteria:

Inclusion Criteria: - Patients who are diagnosed by Bipolar I or II, current episode depressed who require a rapid response due to the severity of their psychiatric or medical condition - Patients of any race and ethnic group - Ability to provide informed consent or assent - Ability to adhere to the study procedures - For females of reproductive potential:use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the end of ECT/transcranial magnetic stimulation (TMS) administration. Of note, ECT is indicated in depression during pregnancy and has been safely used for decades but MST's effects on fetus are still unknown - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner - Has sufficient English in completing self-rated scales - Good general health evidenced by obtained medical clearance before the procedures from another provider - On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. Medication changes can be made during patient's study participation but would be limited to the clinical judgment of the PI Exclusion Criteria: - Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter defibrillators [ICD's], vagus nerve simulators (VNS) and wearable cardioverter-defibrillators (WCD's),ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed - Patients who have conductive, ferromagnetic or other magnetic sensitive metals implanted in their head or within 30 cm of the treatment coil such as stents and bullet fragments).Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients - Patients suffering from vascular, traumatic, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication - Patient suffering from sleep deprivation or alcoholism. Current or unstably remitted substance use disorder except nicotine or caffeine use disorder. Stable remission is defined as remission for at least 6 months - Pregnant or nursing patients - Patients with a history of epilepsy or unexplained seizures - Subjects with a history of space-occupying intracranial pathology - diseases which render a patient likely to suffer hemorrhage, including subdural hematoma, and aortic aneurysm - degenerative diseases of the central nervous system such as dementia or medical illness affecting brain function - Any anaesthesia contraindications including significant cardiac or other medical risk factors. - Body Mass Index over 60, as the investigator's ECT suite stretchers are not equipped to handle overweight patients - History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol,example,borderline personality disorder - Imminent risk of suicide (based on the judgment of the investigators; e.g. patient has a plan for suicide, patient is not likely to seek medical attention in case of suicide, patient exhibits the presence of current suicidal ideation - Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators) - Terminal illness associated with expected survival of <12 months - Bipolar Depression with psychotic features - Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, methohexital, ketamine, propofol, ketorolac - Participation in another drug, device, or biologics trial within the preceding 30 days - Disallowed concomitant medications: antiepileptics and benzodiazepines as they are against seizure therapies, short or mid acting benzodiazepines such as alprazolam, temazepam, midazolam, lorazepam will be allowed but they should be skipped at least 10 hours before the procedures. Medications that are supposed to have weak antiepileptic features such as lamotrigine, topiramate, gabapentin will be reviewed by the PI and either tapered down or discontinued based upon clinical judgment. Lithium will be tapered off before the procedure because of the increased risk of postictal disorientation and delirium.


NCT ID:

NCT04080778


Primary Contact:

Principal Investigator
Salih Selek, MD
The University of Texas Health Science Center, Houston

Salih Selek, MD
Phone: (713) 741-3936
Email: Salih.Selek@uth.tmc.edu


Backup Contact:

Email: Ana.C.Ruiz@uth.tmc.edu
Ana Ruiz
Phone: (713) 741-3951


Location Contact:

Houston, Texas 77030
United States

Salih Selek, MD
Phone: 713-741-3936
Email: Salih.Selek@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 01, 2022

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