Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

Major Depression Clinical Trial

Official title:

Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806143
• Other study ID #: TMSDEP
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2008
• Last updated: February 23, 2011
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2011
• Source: Institute of Neuroscience, Florence, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.

Description:

To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score = 18

• Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks

Exclusion Criteria:

• Any comorbid axis I disorder (except simple and social phobia)

• Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)

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
• Major Depression

Intervention

Device:
• repetitive transcranial stimulation (rTMS)
Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils. In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days.
• unilateral stimulation
Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation

Locations

Country	Name	City	State
Italy	Institute of Neuroscience	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Neuroscience, Florence, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-D)		at baseline and 3rd week	No
Secondary	Clinical Global Impression Scale (CGI)		baseline and 3rd week	No

External Links

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