rTMS in Elderly Depressed:Neuronavegated Study
|ClinicalTrials.gov Identifier: NCT01255072|
Recruitment Status : Unknown
Verified May 2007 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : December 7, 2010
Last Update Posted : June 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|DEPRESSION||Procedure: Transcranial Magnetic Stimulation Procedure: Repetitive Transcranial Magnetic Stimulation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||December 2011|
Active Comparator: 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.
Procedure: 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 Name: TMS
Sham Comparator: 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.
Procedure: Transcranial Magnetic Stimulation
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Other Name: Sham TMS
- Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment. [ Time Frame: 30 months ]evaluation also by Geriatric Depression Scale (GDS)
- Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment. [ Time Frame: 30 months ]recruting
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255072
|Contact: Bianca B. Bellini||+5511 email@example.com|
|Contact: TMS Department||+5511 firstname.lastname@example.org|
|Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school||Recruiting|
|São Paulo, Brazil|
|Contact: TMS Department +5511 3069 8159 email@example.com|
|Principal Investigator:||Bianca B. Bellini||Department and Institute os Psychiatry, General Hospital, University Of São Paulo|