Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Device: Thetaburst Stimulation; Device: High frequency rTMS; Device: Placebo Stimulation

• Registration Number: NCT01240083
• Lead Sponsor: University of Regensburg

Brief Summary

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.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thetaburst Stimulation	Thetaburst Stimulation	1: Thetaburst stimulation: right DLPFC continuous TBS followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 stimuli, 80% motorthreshold
High frequency rTMS	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
Placebo Stimulation	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

Primary Outcome Measures

Name	Time	Method
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)	19 days

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Regensburg- Dept of Psychiatry; 🇩🇪 Regensburg, Bavaria, Germany