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

Erika Forbes

Status: Enrolling

Conditions: Depression

Treatments: Device: Theta Burst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05436379

STUDY21060041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TBS

Other group

Description:

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.

Treatment:

Device: Theta Burst Stimulation