Depression Clinical Trial
— ACDCOfficial title:
Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression
Verified date | April 2014 |
Source | University of Regensburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Episode of depression (unipolar or bipolar)( ICD-10) - Female or male between 18 and 70 years old - Skills to participate in all study procedures - 18 or more points in the Hamilton rating scale or depression - Stable antidepressant drugs - Written informed consent Exclusion Criteria: - Clinically relevant unstable internal or neurological comorbidity - Evidence of significant brain malformations or neoplasm, head injury - Cerebral vascular events - Neurodegenerative disorders affecting the brain or prior brain surgery - Metal objects in and around body that can not be removed - Pregnancy - Alcohol or drug abuse - Epilepsy or a pathological EEG - Heart pacemaker - High dose tranquillizers |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Regensburg- Dept of Psychiatry | Regensburg |
Lead Sponsor | Collaborator |
---|---|
University of Regensburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Change in the Alertness (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19) | Day 19 | No | |
Secondary | Change in the Alertness (Baseline versus follow-up I/ day 47) | Day 47 | No | |
Secondary | Change in the Alertness (Baseline versus follow-up II/ day 75) | Day 75 | No | |
Secondary | Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47) | Day 47 | No | |
Secondary | Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75) | Day 75 | No | |
Secondary | Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47) | Day 47 | No | |
Secondary | Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75) | Day 75 | No | |
Secondary | Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47) | Day 47 | No | |
Secondary | Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75) | Day 75 | No | |
Secondary | Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47) | Day 47 | No | |
Secondary | Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75) | Day 75 | No |
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