Accelerated iTBS for Depression and Suicidality

Launched by UNIVERSITY OF IOWA · Jun 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called accelerated intermittent theta burst stimulation (aiTBS) for people suffering from severe depression and suicidal thoughts. The goal is to see if this high-dose treatment is safe and tolerable for patients who have not responded well to other treatments, like medications or therapy. Participants will be compared to those receiving electroconvulsive therapy (ECT), a common treatment for severe depression. By understanding how well aiTBS works compared to ECT, researchers hope to improve future treatments for depression.

To be eligible for this trial, participants should be between 18 and 90 years old and diagnosed with major depressive disorder. They must have tried at least two different types of antidepressant treatments without success and be willing to follow the study's procedures. Participants will undergo aiTBS treatment and will need to be available for the duration of the study. It's important to note that there are certain health conditions and situations, like having metal implants or being pregnant, that would exclude someone from participating. Throughout the study, participants can expect close monitoring and support from the research team as they explore this potential new treatment for depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Ability to provide informed consent
• • Availability for the duration of the study and willingness to comply with all study procedures
• • Age 18 to 90
• • Diagnosis of major depressive disorder by DSM-5 criteria
• • Depressive symptoms are thought to be caused primarily by a major depressive episode and not by some other neurologic or psychiatric illness
• • Failure of or intolerance to at least 2 antidepressant treatments of different therapeutic classes (can include psychotherapy trial or neurostimulation trial)
• • Meets criteria for clinical eligibility for ECT treatment, including optimization of any medical conditions and completion of any medical testing or clearance as clinically indicated
• • Able to consent voluntarily to treatment
• • Score of at least 2 on the MADRS item 10
• • Ability to sit or lie down for an extended period of time and willingness to adhere to the theta burst stimulation protocol
• Exclusion Criteria:
• • • Presence of implanted ferromagnetic devices or materials, including cardiac pacemaker, cochlear implant, deep brain stimulation device, vagus nerve stimulation device, shrapnel, facial or scalp piercings that cannot be removed, or metallic face or head tattoos
• • Pregnancy or lactation
• • Previous bad reaction or intolerance to transcranial magnetic stimulation
• • Febrile illness within 1 week
• • Treatment with another investigational drug or other intervention within 30 days
• • Recent substance abuse or use disorder within the past 6 months, excluding tobacco or infrequent cannabis use
• • History of epilepsy or seizure disorder
• • History of penetrating traumatic brain injury, multiple sclerosis, or history of brain surgery or intracranial hemorrhage
• • Primary psychiatric or medical/neurologic illness other than MDD that is more likely to account for depressive symptoms, including severe personality disorder or psychotic illness
• • Severe or moderate intellectual disability
• • Major neurocognitive disorder
• • Involuntary commitment or petition filed for involuntary ECT treatment