Recruiting

Brain Stimulation

Sponsor:

Marta Peciña, MD PhD

Code:

NCT06976840

Conditions

Depression

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Intermittent theta burst stimulation

Sham theta burst stimulation

Continuous theta burst stimulation

Study Details

Brief summary:

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.

Conditions

Depression

Major Depressive Disorder

Study ID

NCT06976840

Start date

May 15, 2026

Status verified date

Nov, 2025

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Adults ages 18-55 (\~60% female).
2. Diagnosis of Major Depressive Disorder (MDD) with or without comorbid anxiety disorders (e.g., panic disorder) or Axis II disorders.
3. Psychotropic-free at enrollment.

Exclusion Criteria:

1. being pregnant or breastfeeding;
2. diagnosis of psychotic depression, schizophrenia, bipolar disorder, or other Axis I disorders, except for anxiety disorders;
3. severe substance use (excluding nicotine) in the last 2 months as determined by using the MINI, a structured interview that uses the Diagnostic and Statistical Manual of Mental Disorders;
4. requiring immediate hospitalization;
5. epilepsy or conditions requiring an anticonvulsant;
6. receiving vagus nerve stimulation, electroconvulsive therapy (ECT), or TMS in the last 2 months;
7. currently taking or have taken within the last 21 days psychiatric medication or augmenting agents;
8. receiving depression-specific psychotherapy;
9. actively suicidal or considered a high suicide risk;
10. enrolled in another study; or
11. MRI/TMS contraindication as determined by the fMRI and TMS screening questionnaires

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Salience Network Target

Intermittent/Sham/Continuous TBS, counterbalanced in order.

experimental: Default Mode Network Target

Intermittent/Sham/Continuous TBS, counterbalanced in order.

Interventions

Intermittent theta burst stimulation

Aimed at potentiating the stimulation target.

Sham theta burst stimulation

No effect is expected on stimulation target

Continuous theta burst stimulation

Aimed at depotentiating the stimulation target

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. ]
  • BOLD Signal Change in the Default Mode Network During the fMRI Experiment [ Time Frame: Assessed at approximately day 7, day 14, and day 21 following baseline. ]
  • Changes in Mood Ratings Following TBS and the fMRI Experiment [ Time Frame: Baseline ]
  • Subcute Mood Change Following TBS and the fMRI experiment [ Time Frame: Approximately at day 7, 14, and 21 ]

Central Contacts and Locations

Central contacts

Eli Strohecker, BS

412-246-6147stroheckereg@upmc.edu

Gaurav Badhan, BS

badhang@upmc.edu

Locations

Bellefield Towers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Eli Strohecker, BS

412- 246-6147stroheckereg@upmc.edu

Gaurav Badhan, BS

badhang@upmc.edu

Principal Investigator:

Marta Pecina, MD, PhD

More Information

Sponsor

Marta Peciña, MD PhD

Last update posted

May 22, 2026

Last verified

Nov, 2025

Keywords

  • theta burst stimulation
  • reinforcement learning
  • neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marta Peciña, MD PhD on 2026-05-22.