Depression Clinical Trial
Official title:
Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression
Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.
Status | Completed |
Enrollment | 61 |
Est. completion date | October 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Episode of depression (unipolar or bipolar)( ICD-10) - Female or male between 18 and 70 years - Skills to participate in all study procedures - 18 or more points in the Hamiliton 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), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Regensburg- Dept of Psychiatry | Regensburg | Bavaria |
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) | 19 days | No | |
Secondary | Change in the Beck Depression Inventar, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, the Alertness (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75) | 75 days | No | |
Secondary | Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75) | 75 days | No |
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