Status:
COMPLETED
Pre-mapping Networks for Brain Stimulation 2
Lead Sponsor:
University Medical Center Goettingen
Conditions:
Depressive Episode
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossov...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 and 60 years
- 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
- Neurological diseases, current or previous
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05260086
Start Date
April 15 2019
End Date
May 12 2022
Last Update
May 19 2022
Active Locations (1)
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1
Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)
Göttingen, Germany