Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression

Depression Clinical Trial

— ACDC  

Official title:

Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460758
• Other study ID #: Uni-Reg-ACDC01
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: April 25, 2014
• Start date: April 2011
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Medial Frontal rTMS Double-Cone-Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold.
• Left DLPFC Butterfly Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold.
• Placebo Stimulation
Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold

Locations

Country	Name	City	State
Germany	University of Regensburg- Dept of Psychiatry	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Change in the Alertness (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)		Day 19	No
Secondary	Change in the Alertness (Baseline versus follow-up I/ day 47)		Day 47	No
Secondary	Change in the Alertness (Baseline versus follow-up II/ day 75)		Day 75	No
Secondary	Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47)		Day 47	No
Secondary	Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75)		Day 75	No
Secondary	Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)		Day 47	No
Secondary	Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)		Day 75	No
Secondary	Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)		Day 47	No
Secondary	Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)		Day 75	No
Secondary	Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)		Day 47	No
Secondary	Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)		Day 75	No