Status:
UNKNOWN
rTMS in Elderly Depressed:Neuronavegated Study
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
DEPRESSION
Eligibility:
All Genders
60-75 years
Phase:
PHASE2
Brief Summary
This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study...
Detailed Description
Most part of the studies uses samples of severe depressive patients with refractoriness and/or psychotic symptoms, which leave lacuna about the effects on depressive disorder with low or moderate scor...
Eligibility Criteria
Inclusion
- METHODS:Forty patients with the following criteria:
- Inclusion Criteria
- Patients who meet criteria for Major Depressive Episode (MDE) (DSM-IV, 1994; SCID-P, 1994);
- 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:
- metallic cerebral implants
- 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:
- Hamilton Depression Rating Scale-17 items
- Geriatric Depression Scale (GDS)
- Mini Mental State Examination
- Clock Drawing Test
- Clinical Dementia Rating
- Visual Analogue Scale
- Clinical Global Impression.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01255072
Start Date
August 1 2009
End Date
December 1 2011
Last Update
June 30 2011
Active Locations (1)
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1
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, São Paulo, Brazil