Treatment, Emotion, and Neuromodulation of Depression (TREND) Study

Study Overview
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Brief Summary
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The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.

Detailed Description
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The study has a longitudinal design in which participants complete a baseline assessment, 20 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered twice/day, 5 days/week, for 2 weeks. This procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed SAINT protocol. A subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of TBS sessions. In this study, response to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.

Official Title
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Treatment, Emotion, and Neuromodulation of Depression (TREND) Study

Conditions
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Depression

Intervention / Treatment
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* Device: Theta Burst Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder Exclusion Criteria: Bipolar disorder (lifetime) Obsessive-compulsive disorder (lifetime) History of psychosis Daily use of nicotine Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB) Past 6 month substance use disorder Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke History of head trauma with a loss of consciousness (e.g., concussion) History of seizures MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body Pregnancy Current use of Clozapine, Bupropion, or prescription stimulants Current use of benzodiazepines or mood stabilizers Body shape/size too large to fit in MRI scanner Claustrophobia Metal in the head or ferromagnetic metal in the rest of the body Implanted medical devices High-risk suicidality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The proposed study will use theta burst stimulation (TBS) in an open-label, non-randomized open study for young adults with depression. The study will include measurement of brain function before and after TBS to investigate treatment mechanisms. A subset of participants will also complete a training to enhance positive emotions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TBS<br>In this open-label trial, all participants will undergo 2 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds. There is only 1 group and 1 arm of the study. All participants will receive the treatment. | Device: Theta Burst Stimulation<br>* TBS, a next-gen form of transcranial magnetic stimulation (TMS), requires shorter duration and frequency of stimulation and provides comparable clinical efficacy to traditional repetitive TMS for depression. Thus it is an appropriate technique for use with young adults with depression. TBS can be delivered safely and effectively on an accelerated schedule with two sessions/day. Based on an earlier (ongoing) study of TBS to dorsomedial prefrontal cortex, investigators will administer TBS to dmPFC over 2 weeks in young adults with depression. Addressing the behavioral aspects of anhedonia and reward processing, a subset of participants will also receive positive affect training. Magnetic resonance imaging will guide the personalized location of TBS and will be used to examine change in frontostriatal circuitry with TBS. This study has the potential to influence development of new treatments for depression and anhedonia, with possible mechanisms in frontostriatal brain function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression severity | Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positive Affect, Theta Burst Stimulation