- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240083
Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression
Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.
In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bavaria
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Regensburg, Bavaria, Germany, 93053
- University of Regensburg- Dept of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thetaburst Stimulation
1: Thetaburst stimulation: right DLPFC continuous TBS followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 stimuli, 80% motorthreshold
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Thetaburst stimulation: continuous TBS over the right DLPFC, followed by intermitted TBS over the left DLPFC, each with 50 Hz, together 1200 stimuli (80% motorthreshold)
Other Names:
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Experimental: High frequency rTMS
2: Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC, 110% motor threshold, followed by 1000 stimuli of 10 Hz over the left DLPFC , 110% motorthreshold
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Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC (110% motor threshold)followed by 1000 stimuli of 10 Hz over the left DLPFC (110% motorthreshold)
Other Names:
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Experimental: Placebo Stimulation
3: Sham Stimulation (Sham coil): right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold
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Sham Stimulation (Sham coil):right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
Time Frame: 19 days
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19 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: 75 days
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75 days
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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)
Time Frame: 75 days
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75 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, University of Regensburg- Dept. of Psychiatry
- Principal Investigator: Michael Landgrebe, MD, University of Regensburg, Dept. of Psychiatry
- Principal Investigator: Julia Burger, MD, University of Regensburg- Dept. of Psychiatry
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uni-Reg-TB1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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