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

This study has been completed.
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 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Depression
Device: Thetaburst Stimulation
Device: High frequency rTMS
Device: Placebo Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression

Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 61
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240083

Locations
Germany
University of Regensburg- Dept of Psychiatry
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
University of Regensburg
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
  More Information

No publications provided

Responsible Party: Berthold Langguth, MD, Ph.D., MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT01240083     History of Changes
Other Study ID Numbers: Uni-Reg-TB1
Study First Received: November 12, 2010
Last Updated: October 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:
Depression
Transcranial magnetic stimulation
Thetaburst Stimulation
Alternative treatment methods

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014