Clinical trial NCT05436379: Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Official title: Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Positive Affect
Theta Burst Stimulation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: depression severity
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The University of Pittsburgh, Department of Psychiatry
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Erika E Forbes, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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