Depression Clinical Trial
— ORIENTOfficial title:
Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
Verified date | December 2022 |
Source | University of Regensburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.
Status | Completed |
Enrollment | 15 |
Est. completion date | October 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ICD-10: F60.30 or F60.31 - depressive symptoms and HAMD-21 score of at least 7 - sex: female and male - residence in Germany and German speaking - written informed consent Exclusion Criteria: - meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump) - neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma) - participation in another study parallel to the Trial - other mental or somatic illness which is not compatible with participation according to the principal investigator - pregnancy or breastfeeding period - psychiatric confinement |
Country | Name | City | State |
---|---|---|---|
Germany | University of Regensburg | Regensburg |
Lead Sponsor | Collaborator |
---|---|
University of Regensburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton depression rating scale (HDRS) | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores | 4 weeks | |
Secondary | Major Depression Inventory (MDI) | measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks | |
Secondary | Clinical global impression (CGI) | measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms | 2 weeks, 4 weeks, 12 weeks | |
Secondary | Depression module of the Patient health questionnaire (PHQ-D) | measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores | 4 weeks, 12 weeks | |
Secondary | Barratt impulsiveness Scale (BIS) | measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores | 4 weeks, 12 weeks | |
Secondary | Numeric rating scale of pain | Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10 | 2 weeks, 4 weeks | |
Secondary | nicotine use | number of smoked cigarettes per day (the higher the value the higher the use) | 2 weeks, 4 weeks, 12 weeks | |
Secondary | Hamilton depression rating scale (HDRS) | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks | |
Secondary | Borderline Symptom List (BSL-23) | measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks |
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