Theta burst stimulation and positive affect training for depression
Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
This study is testing if a new brain stimulation technique, along with training to boost positive feelings, can help people with depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 26 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05436379 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of theta burst stimulation (TBS) on reducing depression symptoms in participants diagnosed with a depressive disorder. Participants will undergo a series of 20 TBS sessions over two weeks, with some receiving additional training to enhance positive affect. The study includes baseline assessments, post-treatment evaluations, and follow-up assessments four months later to measure changes in depression severity. The goal is to achieve a significant reduction in reported symptoms, defined as a greater than 50% decrease.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with a current depressive disorder who do not have a history of certain psychiatric or neurological conditions.
Not a fit: Patients with bipolar disorder, substance use disorders, or significant neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for individuals suffering from depression.
How similar studies have performed: Previous studies using theta burst stimulation have shown promise in treating depression, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- The University of Pittsburgh, Department of Psychiatry — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Erika E Forbes, Ph.D — University of Pittsburgh
- Study coordinator: Ashley Pogue, B.A.
- Email: pogueam@upmc.edu
- Phone: 4123549297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.