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

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

Recruiting
18-26 years
All
Phase N/A

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Overview

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.

Description

The study has a longitudinal design in which participants complete a baseline assessment, 20 or 30 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered two or three times a 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.

Eligibility

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

Study details
    Depression

NCT05436379

Erika Forbes

28 June 2025

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