Depression
Conditions
Keywords
Positive Affect, Theta Burst Stimulation
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 or 30 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered two or three times a 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.
Interventions
DEVICETheta 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.
Sponsors
Erika Forbes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| depression severity | up to 1 year | Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member |
Countries
United States
Outcome results
None listed