CompletedNot Applicable

Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep

Germany102 participantsStarted 2021-05-03

Plain-language summary

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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant is able to provide consent. * Diagnosis of major depressive disorder (MDD) according to DSM-V criteria. * During the current episode, treatment-resistant MDD (at least one failed pharmacological trial of adequate dose and duration) * For the MDD group with comorbid borderline personality disorder (BPD): diagnosis of BPD according to the Diagnotic Statistical Manual V (DSM-V) criteria. * For healthy controls: no psychiatric or neurological illness. Exclusion Criteria: * For the MDD group without BPD: BPD diagnosis * The participant does not fulfill requirements for iTBS treatment according to safety guidelines. * The participant does not fulfill requirements for MRI measurements according to safety guidelines. * Pregnancy or breast-feeding. * Acute suicidality. * Neurological illness (e.g. dementia, Parkinson's disease, chorea huntington, multiple sclerosis). * increased current risk for epileptic seizure. * comorbid diagnosis of schizophrenia or psychotic symptoms, bipolar disorder, and substance use disorder within the last 6 months. * Conditions related to increased intracranial pressure. * Brain injury or stroke.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in depression severity after the treatment phase

Timeframe: Up to 5 weekdays after the last iTBS treatment session

Change in BPD severity after the treatment phase

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Up to 5 weekdays before the first and after the last treatment session

Trial details

NCT IDNCT04832750

SponsorUniversity of Oldenburg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More Major Depressive Episode trials