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

Erika Forbes21 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Theta Burst StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 26 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Pittsburgh, Department of Psychiatry

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

depression severity

Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member

Time frame: up to 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.