NCT04832750Completed
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 26 Mar 2021
- Start date
- 3 May 2021
- Primary completion date
- 14 Jun 2024
- Lead sponsor
- University of Oldenburg
- Diseases
- Depression
- NCT number
- NCT04832750
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 3 May 2021 to the primary completion date, 14 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, University of Oldenburg Coordinator of this site? Confirm its status | Bad Zwischenahn | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.