Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Marta Peciña, MD PhD
Study ID
NCT06976840
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Intermittent theta burst stimulation — DEVICE
    Aimed at potentiating the stimulation target.
  • Sham theta burst stimulation — DEVICE
    No effect is expected on stimulation target
  • Continuous theta burst stimulation — DEVICE
    Aimed at depotentiating the stimulation target

Study Details

The goal of this clinical trial is to learn how different types of non-invasive brain stimulation affect mood and brain function in adults with major depressive disorder (MDD). It will also study how brain stimulation may work together with antidepressant treatments. The main questions this study aims to answer are: How do different patterns of brain stimulation affect mood in people with depression? Do brain networks involved in emotion and self-reflection respond differently depending on the type of stimulation? What are the combined effects of brain stimulation and antidepressant treatments on mood and brain activity? Researchers will compare different brain stimulation patterns and target areas to understand their individual and combined effects. Participants will: Receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions Undergo MRI scans during the administration of either a fast-acting or conventional antidepressant. Complete mood assessments during the scan and for one week after each session This study may help identify brain-based strategies to improve treatment for depression. In addition, a subset of participants (\~10) will complete a reward-guided decision-making fMRI task for feasibility purposes.

Key Dates

Start date
May 15, 2026
Status verified
Nov 2025
Primary completion
Aug 1, 2030
Completion
Aug 1, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Other: Salience Network Target
    Intermittent/Sham/Continuous TBS, counterbalanced in order.
  • Experimental: Default Mode Network Target
    Intermittent/Sham/Continuous TBS, counterbalanced in order.

Primary Outcome Measure

Bold Signal Change in the Salience Network During the fMRI Experiment [ Time Frame: Assessed at approximately day 7, day 14, and day 21 following baseline. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bellefield TowersPittsburghPennsylvania15213
Eli Strohecker, BS
412- 246-6147
Gaurav Badhan, BS
Marta Pecina, MD, PhD (PRINCIPAL_INVESTIGATOR)

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