Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2019-04-15
2022-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Personalized aiTBS active - sham
counterbalanced crossover with sham neuronavigated stimulation
Neuronavigated aiTBS
Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
Conventional (F3) aiTBS active - sham
counterbalanced crossover with sham neuronavigated stimulation
Neuronavigated aiTBS
Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
Interventions
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Neuronavigated aiTBS
Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
* Availability of informed consent to participate in the study, including the examinations and interventions
Exclusion Criteria
* Other Axis I diagnoses that mimic the affective disorder, current or previous
* Physical illnesses that could be related to the affective symptoms (so-called organic causes)
* Illicit drug use in the past month
* Substance dependence, current or previous
* Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination
* Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.)
* Pregnancy
* Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.)
* Evidence or history of epilepsy
* Head trauma with a history of loss of consciousness
* Unwillingness to be informed of incidental findings
* Participation in an rTMS / EKT application within the last 8 weeks
* Lack of the ability to provide informed consent
18 Years
60 Years
ALL
No
Sponsors
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University Medical Center Goettingen
OTHER
Responsible Party
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PD Dr. Roberto Goya-Maldonado
Principal Investigator
Principal Investigators
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Roberto Goya-Maldonado, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Göttingen (UMG)
Locations
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Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)
Göttingen, , Germany
Countries
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Other Identifiers
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01759
Identifier Type: -
Identifier Source: org_study_id
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