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

Not Applicable

• Conditions: Treatment Resistant Depression
• Interventions: Device: Intermittent theta-burst stimulation (iTBS)

• Registration Number: NCT03680781
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-13
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated theta burst treatment	Intermittent theta-burst stimulation (iTBS)	All participants will receive theta-burst TMS.

Primary Outcome Measures

Name	Time	Method
Percentage change in Hamilton Depression Rating Scale 21-Item score	Difference between baseline and one month after aiTBS treatment	A 21 item clinical assessment tool used to rate a patient's level of depression - total scores range from 0-63 with higher scores indicating worse depression

Secondary Outcome Measures

Name	Time	Method
Change in Hamilton Rating Scale for Depression (HAMD-6)	Every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone]	rate a patient's level of depression - total scores range from 0-22 with higher scores indicating worse depression
Change from baseline functional connectivity	Pretreatment, immediately post-treatment, 4 weeks post-treatment	We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network.
Change in Hamilton Rating Scale for Depression (HAMD-17)	Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment	A provider administered questionnaire used to rate a patient's level of depression - total scores range from 0-52 with higher scores indicating worse depression
Change in The Scale for Suicide Ideation	Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment	A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide - total scores range from 0-38 with higher scores indicating greater suicidality
Change in Beck Depression Inventory (BDI)	Pretreatment, immediately post-treatment, 4 weeks post-treatment	Self-report measure of depressive symptoms - total scores range from 0-63 with higher scores indicating worse depression
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)	Pretreatment, immediately post-treatment, 4 weeks post-treatment	A 10 item clinician rated measure of depressive symptoms - total scores range from 0-60 with higher scores indicating worse depression

Trial Locations

Locations (1)

Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine; 🇺🇸 Palo Alto, California, United States