Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study

Stanford University

Status: Completed

Conditions: Treatment Resistant Depression

Treatments: Device: Intermittent theta-burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03680781

IRB-44150

Details and patient eligibility

About

This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.

Full description

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 to 75 years of age.
• Able to provide informed consent.
• Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
• prior exposure to rTMS
• Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
• Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
• Participants are required to have a stable psychiatrist for the duration of study enrollment.

Exclusion criteria

• History of MI, CABG, CHF, or other cardiac history
• Any neurological conditions
• History of epilepsy
• OCD
• Independent sleep disorder
• Autism Spectrum Disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Accelerated theta burst treatment

Experimental group

Description:

All participants will receive theta-burst TMS.

Treatment:

Device: Intermittent theta-burst stimulation (iTBS)