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Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
repetitive transcranial stimulation (rTMS)
unilateral stimulation
Sponsored by
Institute of Neuroscience, Florence, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Depression, TMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute of Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

patients will undergo sequential bilateral rTMS treatment

patients will undergo unilateral low frequency right sided DLPFC rTMS

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)

Secondary Outcome Measures

Clinical Global Impression Scale (CGI)

Full Information

First Posted
December 8, 2008
Last Updated
February 23, 2011
Sponsor
Institute of Neuroscience, Florence, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00806143
Brief Title
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Official Title
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Neuroscience, Florence, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Depression, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
patients will undergo sequential bilateral rTMS treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
patients will undergo unilateral low frequency right sided DLPFC rTMS
Intervention Type
Device
Intervention Name(s)
repetitive transcranial stimulation (rTMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
unilateral stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Time Frame
at baseline and 3rd week
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale (CGI)
Time Frame
baseline and 3rd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Pallanti, md
Organizational Affiliation
Istituto di Neuroscienze
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience
City
Florence
ZIP/Postal Code
50122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20144692
Citation
Pallanti S, Bernardi S, Di Rollo A, Antonini S, Quercioli L. Unilateral low frequency versus sequential bilateral repetitive transcranial magnetic stimulation: is simpler better for treatment of resistant depression? Neuroscience. 2010 May 5;167(2):323-8. doi: 10.1016/j.neuroscience.2010.01.063. Epub 2010 Feb 9.
Results Reference
derived

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Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

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