Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments
RADIANT
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started May 2026
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
May 6, 2026
November 1, 2025
4.3 years
April 30, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Bold Signal Change in the Salience Network During the fMRI Experiment
Change in blood oxygenation level-dependent (BOLD) signal within the salience network (SN), measured during the fMRI experiment. Comparisons is made across transcranial magnetic stimulation conditions: intermittent theta burst stimulation (iTBS) vs. sham TBS (sTBS), and continuous TBS (cTBS) vs. sTBS. SN activation is assessed using fMRI contrasts sensitive to expectancy-induced neural modulation.
Assessed at approximately day 7, day 14, and day 21 following baseline.
BOLD Signal Change in the Default Mode Network During the fMRI Experiment
Change in blood oxygenation level-dependent (BOLD) signal within the default mode network (DMN), measured during the fMRI experiment. Comparisons is made across transcranial magnetic stimulation conditions: intermittent theta burst stimulation (iTBS) vs. sham TBS (sTBS), and continuous TBS (cTBS) vs. sTBS. DMN activation is assessed using fMRI contrasts sensitive to expectancy-induced neural modulation.
Assessed at approximately day 7, day 14, and day 21 following baseline.
Changes in Mood Ratings Following TBS and the fMRI Experiment
Change in self-reported mood, coded as a binary indicator of perceived mood improvement (yes/no), is assessed after each TBS session (iTBS, cTBS, sTBS) during the fMRI task. Participants are considered to show mood improvement if their post-stimulation average mood rating across trials increased relative to baseline. Between-condition comparisons (iTBS vs. sTBS; cTBS vs. sTBS) are conducted to evaluate the acute effects of TBS on mood reactivity.
Baseline
Subcute Mood Change Following TBS and the fMRI experiment
Change in depressive symptoms is assessed using the 16-item Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR16; range: 0-27), where higher scores indicate greater depressive symptom severity. The QIDS-SR16 evaluates core domains of depression, including mood, interest, sleep, appetite, and concentration, over the past 7 days. Between-session changes (baseline to days 7, 14, and 21) are analyzed to assess subacute mood effects of intermittent TBS (iTBS), continuous TBS (cTBS), and sham TBS (sTBS) and the fMRI experimental manipulation.
Approximately at day 7, 14, and 21
Study Arms (2)
Salience Network Target
OTHERIntermittent/Sham/Continuous TBS, counterbalanced in order.
Default Mode Network Target
EXPERIMENTALIntermittent/Sham/Continuous TBS, counterbalanced in order.
Interventions
Aimed at potentiating the stimulation target.
No effect is expected on stimulation target
Aimed at depotentiating the stimulation target
Eligibility Criteria
You may qualify if:
- Adults ages 18-55 (\~60% female).
- Diagnosis of Major Depressive Disorder (MDD) with or without comorbid anxiety disorders (e.g., panic disorder) or Axis II disorders.
- Psychotropic-free at enrollment.
You may not qualify if:
- being pregnant or breastfeeding;
- diagnosis of psychotic depression, schizophrenia, bipolar disorder, or other Axis I disorders, except for anxiety disorders;
- 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;
- requiring immediate hospitalization;
- epilepsy or conditions requiring an anticonvulsant;
- receiving vagus nerve stimulation, electroconvulsive therapy (ECT), or TMS in the last 2 months;
- currently taking or have taken within the last 21 days psychiatric medication or augmenting agents;
- receiving depression-specific psychotherapy;
- actively suicidal or considered a high suicide risk;
- enrolled in another study; or
- MRI/TMS contraindication as determined by the fMRI and TMS screening questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marta Peciña, MD PhDlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Bellefield Towers
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Pecina, MD, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 16, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
May 6, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Supporting documentation, including the Study Protocol, Statistical Analysis Plan, Informed Consent Form, and Analytic Code, will be made available upon reasonable request from the journal or other investigators. Furthermore, analytic code and study protocols will be provided as supplemental material at the time of publication of the main findings as deemed appropriate.
- Access Criteria
- Anyone who wishes to access the data.
Consistent with NIMH Data Archive (NDA) policies, the investigators will obtain relevant GUIDs and experiment IDs in order to upload all relevant data biannually. The investigators will use the Validation and Upload Tool for CSV files from behavior during the fMRI experiment, and NIfTI-formatted images for imaging. The investigators will upload study data cumulatively every 6 months per NDA guidelines, with the exception of imaging data, which are will be uploaded in installments. The final research data will not contain any identifiable information and will be deposited in the NIMH Data Archive (NDA). While data is submitted biannually, the complete dataset will be made available for sharing with the research community 24 months after the original study end date. Furthermore, the specific data used for primary analyses will be shared via an NDA Study DOI prior to the acceptance for publication of the main findings.