Clinical trial NCT01460758: Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression
Official title: Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Transcranial magnetic stimulation
rTMS
DLPFC
medial frontal cortex
anterior cingulate complex
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

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 levels 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's 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. Mild antidepressant effects of rTMS applied to the left sided dorsolateral prefrontal cortex (DLPFC) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. First hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be more effective to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

Eligibility criteria: Inclusion Criteria:

* Episode of depression (unipolar or bipolar)( ICD-10)
* Female or male between 18 and 70 years old
* Skills to participate in all study procedures
* 18 or more points in the Hamilton 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: Day 19
Secondary outcomes:
measure: Change in the Alertness (Baseline versus end of treatment/ day 19)
timeFrame: Day 19
measure: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19)
timeFrame: Day 19
measure: Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)
timeFrame: Day 19
measure: Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)
timeFrame: Day 19
measure: Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)
timeFrame: Day 19
measure: Change in the Alertness (Baseline versus follow-up I/ day 47)
timeFrame: Day 47
measure: Change in the Alertness (Baseline versus follow-up II/ day 75)
timeFrame: Day 75
measure: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47)
timeFrame: Day 47
measure: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75)
timeFrame: Day 75
measure: Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)
timeFrame: Day 47
measure: Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)
timeFrame: Day 75
measure: Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)
timeFrame: Day 47
measure: Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)
timeFrame: Day 75
measure: Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)
timeFrame: Day 47
measure: Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)
timeFrame: Day 75
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg- Dept of Psychiatry
Study officials:
affiliation: University of Regensburg - Dep. of Psychiatry
name: Berthold Langguth, MD
role: STUDY_DIRECTOR
affiliation: University of Regensburg, Dpt of Psychiatry
name: Michael Landgrebe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg, Dpt of Psychiatry
name: Peter Kreuzer, MD
role: PRINCIPAL_INVESTIGATOR
References: