Repetitive Transcranial Magnetic Stimulation in Postpartum Depression
NCT ID: NCT01452321
Last Updated: 2011-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2007-08-31
2009-09-30
Brief Summary
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However, up to current days there have been no studies evaluating the effects of rTMS on neurocognitive and social performance of women suffering from the disorder.
The present study evaluates the impacts of rTMS in clinical, cognitive and social performance.
Detailed Description
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The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.
The present technique has never been employed in previous studies, but risks are insignificant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
repetitive transcranial magnetic stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Active rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.
repetitive transcranial magnetic stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Interventions
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repetitive transcranial magnetic stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
* baseline score of at least 13 points on the Edinburgh Postnatal Depression Scale.
* range = 18-36 years
* women who had given birth 1-6 months
* any pharmacological treatment other than clonazepam (1 mg/day)
Exclusion Criteria
* pacemakers
* previous neurosurgery
* history of seizures
* major head trauma
* alcoholism
* drug addiction
* any psychiatric or neurological disorder other than depression and anxiety
* psychotic depression
* suicidal propensities
18 Years
36 Years
FEMALE
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Eduardo Moacyr Krieger
Associate Professor
Principal Investigators
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Martin L Myczkowski, MSD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo General Hospital
Locations
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Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, São Paulo, Brazil
Countries
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References
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Garcia KS, Flynn P, Pierce KJ, Caudle M. Repetitive transcranial magnetic stimulation treats postpartum depression. Brain Stimul. 2010 Jan;3(1):36-41. doi: 10.1016/j.brs.2009.06.001. Epub 2009 Jul 8.
Other Identifiers
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0588/07
Identifier Type: -
Identifier Source: org_study_id