DepressionRADIANTNCT06976840
Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments
A study testing Intermittent theta burst stimulation and Continuous theta burst stimulation in people with Depression and Major Depressive Disorder, run by Marta Peciña, MD PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Intermittent theta burst stimulation and Continuous theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Vigne, BS contact
United States1 site, 1 recruiting
- Recruiting
Bellefield Towers
Pittsburgh, Pennsylvania, 15213
Eli Strohecker, BS, 412- 246-6972, stroheckereg@upmc.edu
Megan Vigne, BS, meganvm@upmc.edu
About this study
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:
Read more
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 (~25) will complete a reward-guided decision-making fMRI task for feasibility purposes.
Read the detailed description
This mechanistic clinical trial will investigate the role of large-scale brain networks in modulating mood responses in adults with major depressive disorder (MDD) using non-invasive neuromodulation and neuroimaging. The study will focus on the salience network (SN), default mode network (DMN), and functional connectivity (FC) between them, given prior evidence linking these systems to mood regulation and antidepressant response.
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. In addition, a subset of participants (~10) will complete a reward learning fMRI task, a reward-guided decision-making, designed to capture value-based decision-making processes.
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
- Depression, Major Depressive Disorder
- Being tested
- Intermittent theta burst stimulation, Sham theta burst stimulation, Continuous theta burst stimulation
- Keywords
- theta burst stimulation, reinforcement learning, neuroimaging
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulationDevice
Aimed at potentiating the stimulation target.
Sham theta burst stimulationDevice
No effect is expected on stimulation target
Continuous theta burst stimulationDevice
Aimed at depotentiating the stimulation target
| Study group | Role | What they receive |
|---|---|---|
| Salience Network Target | Other | Intermittent/Sham/Continuous TBS, counterbalanced in order. Receives: Device: Intermittent theta burst stimulation; Device: Sham theta burst stimulation; Device: Continuous theta burst stimulation |
| Default Mode Network Target | Experimental | Intermittent/Sham/Continuous TBS, counterbalanced in order. Receives: Device: Intermittent theta burst stimulation; Device: Sham theta burst stimulation; Device: Continuous theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately at day 7, 14, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2026
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a mechanistic trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marta Peciña, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Marta Peciña, MD PhD, University of Pittsburgh
- Investigators
- Marta Pecina, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976840
- Sponsor's protocol ID
- STUDY24040131
- Other IDs
- R01MH141091
- Acronym
- RADIANT
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments
- ClinicalTrials.gov ID
- NCT06976840
- Acronym / sponsor ID
- RADIANT / STUDY24040131
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- theta burst stimulation, reinforcement learning, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marta Peciña, MD PhDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (~25) will complete a reward-guided decision-making fMRI task for feasibility purposes.
Detailed description
This mechanistic clinical trial will investigate the role of large-scale brain networks in modulating mood responses in adults with major depressive disorder (MDD) using non-invasive neuromodulation and neuroimaging. The study will focus on the salience network (SN), default mode network (DMN), and functional connectivity (FC) between them, given prior evidence linking these systems to mood regulation and antidepressant response.
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. In addition, a subset of participants (~10) will complete a reward learning fMRI task, a reward-guided decision-making, designed to capture value-based decision-making processes.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a mechanistic trial
| Arm | Type | Receives |
|---|---|---|
| Salience Network Target | Other | Device: Intermittent theta burst stimulation, Device: Sham theta burst stimulation, Device: Continuous theta burst stimulationIntermittent/Sham/Continuous TBS, counterbalanced in order. |
| Default Mode Network Target | Experimental | Device: Intermittent theta burst stimulation, Device: Sham theta burst stimulation, Device: Continuous theta burst stimulationIntermittent/Sham/Continuous TBS, counterbalanced in order. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta burst stimulationAimed at potentiating the stimulation target. | Device | Default Mode Network Target, Salience Network Target |
| Sham theta burst stimulationNo effect is expected on stimulation target | Device | Default Mode Network Target, Salience Network Target |
| Continuous theta burst stimulationAimed at depotentiating the stimulation target | Device | Default Mode Network Target, Salience Network Target |
Primary outcome
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.
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.
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.
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.
Changes in Mood Ratings Following TBS and the fMRI Experiment
Time frame: Baseline
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.
Subcute Mood Change Following TBS and the fMRI experiment
Time frame: Approximately at day 7, 14, and 21
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Vigne, BS contact
Marta Pecina, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation and Continuous theta burst stimulation in people with Depression and Major Depressive Disorder, run by Marta Peciña, MD PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eli Strohecker, BS (412-246-6972, stroheckereg@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.