Image

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

Recruiting
18 - 26 years of age
Both
Phase N/A

Powered by AI

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 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.

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

19 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.