An observational study in Major Depressive Episode, Major Depressive Disorder and Borderline Personality Disorder, sponsored by University of Oldenburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Oldenburg · Observational
Advances in repetitive transcranial magnetic stimulation (rTMS) protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. This randomized, placebo-controlled study investigates the effects of accelerated iTBS treatment with connectivity-informed neuronavigation on symptom severity, sleep, interoception, and cognitive control in patients with major depressive disorder and with or without comorbid borderline personality disorder using magnetic resonance imaging (MRI).
Repetitive transcranial magnetic stimulation (rTMS) is a safe and efficacious treatment option for treatment-resistant depression. Advances in rTMS protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. Major depressive disorder (MDD) is characterized by impairments in various domains including sleep, impulse control, and interoception. Borderline personality disorder (BPD) is characterized by fear of abandonment, mood swings, and an unstable perception of self and often occurs with comorbid MDD. This comorbidity frequently impedes treatment of the BPD.
In this randomized, placebo-controlled study, 60 patients with treatment-resistant MDD (30 verum group, 30 sham group) and 60 patients with treatment-resistant MDD and comorbid BPD (30 verum group, 30 sham group) will receive two weeks of connectivity-informed iTBS of the left dorsolateral prefrontal cortex (DLPFC; 3 sessions per day, 5 days per week). Before and after the treatment phase, (functional) magnetic resonance imaging (fMRI) will be performed. The effects of iTBS will be tested in four domains: (1) symptom severity (MDD and BPD symptoms), (2) sleep quality (sleep questionnaires and various sleep parameters monitored via an electroencephalography (EEG) headband), (3) neurocognitive effects (vigilance and response inhibition measured with behavioral and fMRI tasks), and (4) interoception (interoceptive attention measured with behavioral and fMRI tasks). Furthermore, before the start of the two-weeks treatment, a single iTBS session ("forecaster session") will be conducted to explore the validity of early symptom/mood responses and hormonal changes for the prediction of the the treatment outcome. Treatment effects will be analyzed within and across patient groups (MDD and MDD + BPD). In addition, domain-specific treatment effects will be analyzed as a function of distinct iTBS targets within the DLPFC.To evaluate pathological biases, the investigators will compare the patients' data with a control group of 30 healthy participants who will also be tested twice (without iTBS).
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 102 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Oldenburg is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Patients at the Department of Psychiatry, University of Oldenburg. The patients' diagnosis of MDD and BPD will be verified via the structured clinical interview for DSM-V. Healthy controls will be matched to the patient sample.
Exclusion Criteria:
At least one failed pharmaco trial in current episode
Device: intermittent theta burst stimulation (iTBS) or sham stimulation
At least one failed pharmaco trial in current episode
Device: intermittent theta burst stimulation (iTBS) or sham stimulation
No psychiatric disorders
30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
Change in depression severity after the treatment phase
Measured with the Montgomery Asberg Rating Scale (MARDS). Remission defined as MADRS score (range: 0 to 60) of less than or equal to 10. Response defined as a reduction of at least 50 percent from baseline in MADRS score.
Time frame: Up to 5 weekdays after the last iTBS treatment session
Change in BPD severity after the treatment phase
Measured by the Zanarini rating scale for BPD (Zan-BPD, range 0-36). Remission is defined as score of 9 or less. Response defined as a decrease from baseline in Zan-BPD score of at least 20 percent of the scoring range, i.e. a reduction of 8 points or more.
Time frame: Up to 5 weekdays after the last iTBS treatment session
Changes in neural responses in an interoception task before the first and after the last treatment session
Measured with functional magnetic resonance imaging (fMRI) while performing an interoception task
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in neural responses in a cognitive control task before the first and after the last treatment session
Measured with functional magnetic resonance imaging (fMRI) while performing a cognitive control task
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in behavioral responses in an interoception task before the first and after the last treatment session
Measured as performance in an interoception task during fMRI
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in behavioral responses in a cognitive control task before the first and after the last treatment session
Measured as performance in a cognitive control task during fMRI
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in sleep staging over the treatment course
electroencephalography (EEG)-based sleep staging measured with a headband device with accelerometer and pulseoximeter
Time frame: 2 days of baseline measurement before the first iTBS session, daily over the treatment course for 10 days
Changes in brain connectivity measures
Structural and functional connectivity measured with MRI including graph measures
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in vigilance over the treatment course
Vigilance measured by Psychomotor Vigilance Task (PVT)
Time frame: Baseline immediately before the first iTBS session, daily over the treatment course for 10 days
Changes in symptom severity over treatment course
Measured by the MADRS
Time frame: Baseline immediately before the first iTBS session, after 1 week of treatment, after 2 weeks of treatment, and at the follow-up 6 weeks after treatment
Changes in self-reported symptom severity over treatment course and at follow-up
measured by the Beck Depression Inventory (BDI-II)
Time frame: Baseline immediately before the first iTBS session, daily over the treatment course for 10 days, 6 weeks after last iTBS session at the follow-up
Changes in Cortisol Awakening Response (CAR) from saliva concentrations
3 measurements after awakening (0,20, and 40 minutes)
Time frame: Up to 5 weekdays before the first and after the last treatment session
Changes in blood parameters
Pro- and anti-inflammatory cytokines, and growth factors
Time frame: Before the first and after the last treatment session
Association between changes induced by the Forecaster session and treatment outcome
Changes in biomarkers before and after the forecaster iTBS session
Time frame: Immediately before and after the forecaster iTBS session
Changes in self-reported BPD symptom severity over treatment course and at follow-up
Measured by the Borderline Symptom List (BSL-23) (range 0-4)
Time frame: Baseline immediately before the first iTBS session, daily over the treatment course for 10 days, 6 weeks after last iTBS session at follow-up
Changes in BPD symptom severity over treatment course and at follow-up
Measured by Zan-BPD
Time frame: Baseline immediately before the first iTBS session, after 1 week of treatment, and after 2 weeks of treatment
Changes in food craving
Measured by a behavioral food craving task
Time frame: Up to 5 weekdays before the first and after the last treatment session
Plan to share: Undecided
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University of Oldenburg