Skip to main content
OpenTrials
Completed

NCT Number: NCT01240083

Effectiveness of Theta-burst Stimulation (TBS) 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg- Dept of Psychiatry

Regensburg, Bavaria, 93053, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thetaburst Stimulation

Device

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

High frequency rTMS

Device

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

Placebo stimulation

Device

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

Primary outcomes

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

    Time frame: 19 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2010
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.