Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

This study has been completed.
Sponsor:
Information provided by:
Institute of Neuroscience, Florence, Italy
ClinicalTrials.gov Identifier:
NCT00806143
First received: December 8, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Major Depression
Device: repetitive transcranial stimulation (rTMS)
Device: unilateral stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

Resource links provided by NLM:


Further study details as provided by Institute of Neuroscience, Florence, Italy:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: at baseline and 3rd week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale (CGI) [ Time Frame: baseline and 3rd week ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
patients will undergo sequential bilateral rTMS treatment
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.

Active Comparator: 2
patients will undergo unilateral low frequency right sided DLPFC rTMS
Device: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806143

Locations
Italy
Institute of Neuroscience
Florence, Italy, 50122
Sponsors and Collaborators
Institute of Neuroscience, Florence, Italy
Investigators
Principal Investigator: Stefano Pallanti, md Istituto di Neuroscienze
  More Information

No publications provided by Institute of Neuroscience, Florence, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefano Pallanti, University of Florence
ClinicalTrials.gov Identifier: NCT00806143     History of Changes
Other Study ID Numbers: TMSDEP
Study First Received: December 8, 2008
Last Updated: February 23, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Institute of Neuroscience, Florence, Italy:
Depression
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014