Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMarta Peciña, MD PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Factorial
Treatments tested in this trial
Intermittent theta burst stimulation
DeviceAimed at potentiating the stimulation target.
Sham theta burst stimulation
DeviceNo effect is expected on stimulation target
Continuous theta burst stimulation
DeviceAimed at depotentiating the stimulation target
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Salience Network TargetOther 3 interventions
Group B: Default Mode Network TargetExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at approximately day 7, day 14, and day 21 following baseline.2
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.
Time frame
Assessed at approximately day 7, day 14, and day 21 following baseline.3
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.
Time frame
Baseline4
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.
Time frame
Approximately at day 7, 14, and 21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marta Peciña, MD PhD
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov