Clinical trial NCT01240083: Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression
Official title: Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Transcranial magnetic stimulation
Thetaburst Stimulation
Alternative treatment methods
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
timeFrame: 19 days
Secondary outcomes:
measure: 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)
timeFrame: 75 days
measure: 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)
timeFrame: 75 days
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg- Dept of Psychiatry
state: Bavaria
Study officials:
affiliation: University of Regensburg- Dept. of Psychiatry
name: Berthold Langguth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg, Dept. of Psychiatry
name: Michael Landgrebe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg- Dept. of Psychiatry
name: Julia Burger, MD
role: PRINCIPAL_INVESTIGATOR
References: