Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments
NCT ID: NCT06976840
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2026-01-01
2030-08-01
Brief Summary
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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.
Detailed Description
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Using a 2x3 factorial design, 200 participants with MDD will be randomized to receive theta burst stimulation (TBS) targeting either the SN or the DMN (between-subject factor). Each participant will complete three within-subject TBS sessions one week apart: intermittent TBS (iTBS), continuous TBS (cTBS), and sham stimulation. TBS will be delivered over individualized fMRI-based targets derived from prior resting-state connectivity maps.
Following each stimulation session, participants will complete an MRI protocol that includes administration of either a fast-acting or conventional antidepressant, as well as resting-state functional imaging.
Primary neural outcomes include changes in activation and connectivity within and between SN and DMN regions, measured using task-based and resting-state fMRI. Behavioral outcomes include mood ratings acquired repeatedly during the scanning session and via daily remote assessments for one week post-stimulation.
This design allows for within-subject comparison of the acute and sub-acute effects of different TBS patterns, and between-subject comparison of SN- vs. DMN-targeted stimulation. The study aims to identify brain circuits that can be engaged or modulated to enhance treatment response in depression, with the longer-term goal of informing precision neuromodulation strategies.
Note: Certain information is withheld to protect the scientific integrity of the study design.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
DOUBLE
Study Groups
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Salience Network Target
Intermittent/Sham/Continuous TBS, counterbalanced in order.
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
Default Mode Network Target
Intermittent/Sham/Continuous TBS, counterbalanced in order.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
No
Sponsors
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Marta Peciña, MD PhD
OTHER
Responsible Party
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Marta Peciña, MD PhD
Associate Professor
Principal Investigators
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Marta Pecina, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Bellefield Towers
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Eli Strohecker, BS
Role: primary
Gaurav Badhan, BS
Role: backup
Other Identifiers
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STUDY24040131
Identifier Type: -
Identifier Source: org_study_id