Clinical trial NCT04969549: Response Predictors of Theta-burst Stimulation for Depression
Official title: Use of Functional Neuroimaging Biomarkers as Early Predictors of Response to Theta-burst Stimulation Treatment in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
TBS
fMRI
response predictors
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Academy of Medical Sciences, UK
First posted: 2021-07-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Active TBS.
Primary purpose: TREATMENT

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.

Detailed description: Depressive disorders are among the leading causes of incapacity and disability worldwide. The burden of depression is expected to increase and is associated with negative impact on clinical conditions and physical and cognitive abilities. Given the limited efficacy of antidepressant drugs, novel treatments such as theta-burst brain stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), are being developed. However, to further advance the field towards treatment personalisation, increasing understanding of TBS antidepressant mechanisms and identifying treatment responders are important issues. Moreover, no studies have used neuroimaging in TBS trials in depression yet. Our group in Brazil is a leading brain stimulation centre, although neuroimaging expertise is lacking. We will conduct 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. Scientifically, this proposal and its outcomes will help advance towards next-generation precision brain stimulation, by incorporating cognitive/neuroimaging readouts that inform about mechanism and individual response.

Eligibility criteria: Inclusion Criteria: participants aged from 18 to 65 years, with HDRS score ≥ 14, with MDD confirmed by MINI structured interview.

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Exclusion Criteria: other mental disorders (alcohol or other substance dependence, bipolar disorder, psychotic disorders or dementia), severe clinical or neurological disorders, suicidal ideation, presence of psychotic symptoms, severe depression characterized by HDRS score \> 28, manic symptoms characterized by score \> 8 in the Young Mania Rating Scale. In addition, patients with specific contraindications to magnetic stimulation or magnetic resonance imaging will be excluded, such as having any metallic implants, epilepsy or any electronic component in the head.

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale scores (17-item version)
timeFrame: Week 0 (baseline) and Week 6
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale scores (MADRS)
timeFrame: Week 0 (baseline) and Week 6
measure: Change in Young Mania Rating Scale (YMRS) scores
timeFrame: Week 0 (baseline) and Week 6
measure: Facial Expression Recognition Test (FERT)
timeFrame: Week 0 (baseline) and Week 2.
measure: Change in Positive and Negative Affect Schedule scores (PANAS)
timeFrame: Week 0 (baseline) and Week 6
measure: Change in State-Trait Anxiety Inventory scores (STAI-T and STAI-S)
timeFrame: Week 0 (baseline) and Week 6
measure: Change in functional and structural neuroimaging exam
timeFrame: baseline and after two weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Psiquiatria
state: SP
Study officials:
affiliation: FACULDADE DE MEDICINA DA USP
name: Andre R Brunoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: