Status:
COMPLETED
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
Lead Sponsor:
University of Oldenburg
Collaborating Sponsors:
Marc Onken, M.Sc.
Christina Mueller, M.Sc.
Conditions:
Major Depressive Episode
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 26 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04832750
Start Date
May 3 2021
End Date
July 26 2024
Last Update
December 11 2024
Active Locations (1)
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1
Department of Psychiatry, University of Oldenburg
Bad Zwischenahn, Germany, 26160