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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: Theta Burst Stimulation

• Registration Number: NCT05436379
• Lead Sponsor: Erika Forbes

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-04
• Study Start: 2022-06-17
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TBS	Theta Burst Stimulation	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.

Primary Outcome Measures

Name	Time	Method
depression severity	up to 1 year	Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member

Trial Locations

Locations (1)

The University of Pittsburgh, Department of Psychiatry; 🇺🇸 Pittsburgh, Pennsylvania, United States