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 range18 Years – 65 Years

SexALL

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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.

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

Changes in sleep staging over the treatment course

Trial details

NCT IDNCT04832750

SponsorUniversity of Oldenburg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More Major Depressive Episode trials