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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS + placebo
Patients, free from medication for at least one week (washout of 3 weeks for fluoxetine users) will receive 20 sessions of active rTMS delivered to the left Dorsolateral PreFrontal Cortex. Each patient will take placebo pills for 60 day,starting parallel on the first rTMS day.
Repetitive Transcranial Magnetic Stimulation
20 daily sessions: each one with 25 trains of 10seconds at 5Hz, train interval of 25 seconds (time off), pulse intensity corrected based on atrophy degree by a specific correction formule. Target: left dorsolateral prefrontal cortex.
SHAM
Patients, free from medication at least for one week (washout of 3 weeks for fluoxetine users)receiving 20 sessions of Sham TMS delivered to the left dordolateral prefrontal cortex, at the same time this washed out of antidepressives patients start taking Citalopram 20mg/day, for 60 days.
Transcranial Magnetic Stimulation
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Interventions
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Transcranial Magnetic Stimulation
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Repetitive Transcranial Magnetic Stimulation
20 daily sessions: each one with 25 trains of 10seconds at 5Hz, train interval of 25 seconds (time off), pulse intensity corrected based on atrophy degree by a specific correction formule. Target: left dorsolateral prefrontal cortex.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Severity of the episode of mild to moderate
* Aged between 60 and 75 years;
* Both genders;
* In case of previous depressive episode, complete remission of the same for at least 6 weeks as measured by the clinical history;
* washed out of psychotropic drugs for one week, including antidepressants; except fluoxetine, which must have three week interval;
* Granting a written informed consent to participate in the study (Annex II)
Exclusion Criteria
* history of severe trauma or brain injury
* organic brain disease
* severe somatic disease
* history of other psychiatric diseases
* history of Epilepsy
* Non cooperating patients
Scales and Tests of clinical evaluation:
1. Hamilton Depression Rating Scale-17 items
2. Geriatric Depression Scale (GDS)
3. Mini Mental State Examination
4. Clock Drawing Test
5. Clinical Dementia Rating
6. Visual Analogue Scale
7. Clinical Global Impression.
60 Years
75 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
Principal Investigators
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Bianca B. Bellini
Role: PRINCIPAL_INVESTIGATOR
Department and Institute os Psychiatry, General Hospital, University Of São Paulo
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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Central Contacts
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Facility Contacts
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TMS Department
Role: primary
Other Identifiers
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BBellini - 0996/07
Identifier Type: -
Identifier Source: org_study_id