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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01240083
First received: November 12, 2010
Last updated: October 21, 2011
Last verified: October 2011
History of Changes

November 12, 2010
October 21, 2011
April 2010
September 2011   (final data collection date for primary outcome measure)
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) [ Time Frame: 19 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01240083 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depression
  • Device: Thetaburst Stimulation
    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:
    • Transcranial Magnetic Stimulation
    • Theta-burst
  • Device: High frequency rTMS
    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:
    • Transcranial Magnetic Stimulation,
    • High frequency repetitive TMS
  • Device: Placebo Stimulation
    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:
    • Transcranial Magnetic Stimulation
    • Sham Stimulation
  • 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
    Intervention: Device: Thetaburst Stimulation
  • 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
    Intervention: Device: High frequency rTMS
  • 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
    Intervention: Device: Placebo Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01240083
Uni-Reg-TB1
No
Berthold Langguth, MD, Ph.D., University of Regensburg
University of Regensburg
Not Provided
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
University of Regensburg
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP