Anxiety & Depression Association of America

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

Purpose

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.

Condition

Depression

Eligibility

Eligible Ages: Between 18 Years and 26 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The proposed study will use theta burst stimulation (TBS) in an open-label, non-randomized open study for young adults with depression. The study will include measurement of brain function before and after TBS to investigate treatment mechanisms. A subset of participants will also complete a training to enhance positive emotions.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other TBS	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.	Device: Theta Burst Stimulation 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Erika Forbes

Study Contact

Ashley Pogue, B.A.
4123549297
pogueam@upmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.