Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

NCT00806143 | Completed Phase 4 DMC

• 1 other identifier: TMSDEP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Depression; TMS

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale (HAM-D)

  at baseline and 3rd week

Secondary Outcomes (1)

• Clinical Global Impression Scale (CGI)

  baseline and 3rd week

Study Arms (2)

1

ACTIVE COMPARATOR

patients will undergo sequential bilateral rTMS treatment

Device: repetitive transcranial stimulation (rTMS)

2

ACTIVE COMPARATOR

patients will undergo unilateral low frequency right sided DLPFC rTMS

Device: unilateral stimulation

Interventions

repetitive transcranial stimulation (rTMS) DEVICE

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.

1

unilateral stimulation DEVICE

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any comorbid axis I disorder (except simple and social phobia)
• Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)

Sponsors & Collaborators

• Institute of Neuroscience, Florence, Italy: lead

Study Sites (1)

Institute of Neuroscience

Florence, 50122, Italy

Location

Related Publications (1)

• 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.

  PMID: 20144692 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Stefano Pallanti, md

  Istituto di Neuroscienze

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

IT (1)