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Completed

NCT Number: NCT04969549

Response Predictors of Theta-burst Stimulation for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Psiquiatria

São Paulo, 05403-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

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.

Treatment and study plan

Theta Burst Stimulation

Other

It consists of 20 sessions of iTBS over the dlPFC.

Other names: TBS

Primary outcomes

  1. Change in Hamilton Depression Rating Scale scores (17-item version)

    Time frame: Week 0 (baseline) and Week 6

    Clinician-administered depression assessment scale. Score range = 0 - 52 (higher scores mean worse outcome).

Secondary outcomes

  1. Change in Montgomery-Asberg Depression Rating Scale scores (MADRS)

    Time frame: Week 0 (baseline) and Week 6

    Clinician-administered depression assessment scale. Score range = 0 - 60 (higher scores mean worse outcome).

  2. Change in Young Mania Rating Scale (YMRS) scores

    Time frame: Week 0 (baseline) and Week 6

    Clinician-administered scale that measures hypomania/mania symptoms. Score range = 0 - 60 (higher scores mean worse outcome).

  3. Facial Expression Recognition Test (FERT)

    Time frame: Week 0 (baseline) and Week 2.

    Cognitive test used to detect emotional bias.

  4. Change in Positive and Negative Affect Schedule scores (PANAS)

    Time frame: 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).

  5. Change in State-Trait Anxiety Inventory scores (STAI-T and STAI-S)

    Time frame: 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.

  6. Change in functional and structural neuroimaging exam

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Academy of Medical Sciences, UK

Registry information

Official study title

Use of Functional Neuroimaging Biomarkers as Early Predictors of Response to Theta-burst Stimulation Treatment in Depression

Acronym: TBS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 20, 2021
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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