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

E

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)

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

Trial contacts and locations

1

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Central trial contact

Study Coordinator; Ashley Pogue, B.A.

Data sourced from clinicaltrials.gov

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