Response Predictors of Theta-burst Stimulation for Depression
TBS
Use of Functional Neuroimaging Biomarkers as Early Predictors of Response to Theta-burst Stimulation Treatment in Depression
2 other identifiers
interventional
52
1 country
1
Brief Summary
The study consists of an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started May 2021
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2021
CompletedFirst Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2023
CompletedFebruary 26, 2024
February 1, 2024
1.5 years
July 16, 2021
February 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hamilton Depression Rating Scale scores (17-item version)
Clinician-administered depression assessment scale. Score range = 0 - 52 (higher scores mean worse outcome).
Week 0 (baseline) and Week 6
Secondary Outcomes (6)
Change in Montgomery-Asberg Depression Rating Scale scores (MADRS)
Week 0 (baseline) and Week 6
Change in Young Mania Rating Scale (YMRS) scores
Week 0 (baseline) and Week 6
Facial Expression Recognition Test (FERT)
Week 0 (baseline) and Week 2.
Change in Positive and Negative Affect Schedule scores (PANAS)
Week 0 (baseline) and Week 6
Change in State-Trait Anxiety Inventory scores (STAI-T and STAI-S)
Week 0 (baseline) and Week 6
- +1 more secondary outcomes
Study Arms (1)
Theta-burst stimulation (TBS)
OTHERReceive active iTBS, 1800 pulses, 100% MT over dlPFC.
Interventions
It consists of 20 sessions of iTBS over the dlPFC.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Academy of Medical Sciences, UKcollaborator
Study Sites (1)
Instituto de Psiquiatria
São Paulo, São Paulo, 05403-903, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre R Brunoni, MD, PhD
FACULDADE DE MEDICINA DA USP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of the Medical School of the University of Sao Paulo (FMUSP), Principal Investigator
Study Record Dates
First Submitted
July 16, 2021
First Posted
July 20, 2021
Study Start
May 13, 2021
Primary Completion
November 28, 2022
Study Completion
November 28, 2023
Last Updated
February 26, 2024
Record last verified: 2024-02