Response Predictors of Theta-burst Stimulation for Depression
- Conditions
- Depression
- Interventions
- Other: Theta burst stimulation
- Registration Number
- NCT04969549
- Lead Sponsor
- University of Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
participants aged from 18 to 65 years, with HDRS score ≥ 14, with MDD confirmed by MINI structured interview.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Theta-burst stimulation (TBS) Theta burst stimulation Receive active iTBS, 1800 pulses, 100% MT over dlPFC.
- Primary Outcome Measures
Name Time Method Change in Hamilton Depression Rating Scale scores (17-item version) Week 0 (baseline) and Week 6 Clinician-administered depression assessment scale. Score range = 0 - 52 (higher scores mean worse outcome).
- Secondary Outcome Measures
Name Time Method Change in Positive and Negative Affect Schedule scores (PANAS) Week 0 (baseline) and Week 6 Self-report questionnaire to measure both positive and negative affect. Positive Affect Score: scores can range from 10 - 50, with higher scores representing higher levels of positive affect (better outcome). Negative Affect Score: scores can range from 10 - 50, with higher scores representing higher levels of negative affect (worse outcome).
Change in Young Mania Rating Scale (YMRS) scores Week 0 (baseline) and Week 6 Clinician-administered scale that measures hypomania/mania symptoms. Score range = 0 - 60 (higher scores mean worse outcome).
Change in Montgomery-Asberg Depression Rating Scale scores (MADRS) Week 0 (baseline) and Week 6 Clinician-administered depression assessment scale. Score range = 0 - 60 (higher scores mean worse outcome).
Facial Expression Recognition Test (FERT) Week 0 (baseline) and Week 2. Cognitive test used to detect emotional bias.
Change in State-Trait Anxiety Inventory scores (STAI-T and STAI-S) Week 0 (baseline) and Week 6 Self-report measures of state and trait anxiety. The range of possible scores for each subscale (STAI-T and STAI-S) varies from a minimum score of 20 to a maximum score of 80, with higher scores meaning worse outcome.
Change in functional and structural neuroimaging exam baseline and after two weeks Neuroimaging exam used to measure both functional and structural aspects of the brain as possible predictors of clinical response to treatment.
Trial Locations
- Locations (1)
Instituto de Psiquiatria
🇧🇷Sao Paulo, SP, Brazil