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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 of rTMS in elderly depressed patients.
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 scores. The literature is poor about the use of Repetitive Transcranial Magnetic Stimulation (rTMS) in the old age population.Therefore, we chose this group to research for the antidepressive effect of TMS; other interests are to identify modifications in the magnetic resonance imaging, evaluate cognitive functions and to verify the occurrence of collateral effects and safety use for this specific population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS + placebo | Active Comparator | 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. |
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| SHAM | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Procedure | 20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | evaluation also by Geriatric Depression Scale (GDS) | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | recruting | 30 months |
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METHODS:Forty patients with the following criteria:
Inclusion Criteria
Exclusion Criteria:
Scales and Tests of clinical evaluation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bianca B. Bellini | Contact | +5511 30698159 | bellinibianca@yahoo.com.br | |
| TMS Department | Contact | +5511 30698159 | emt@hcnet.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Bianca B. Bellini | Department and Institute os Psychiatry, General Hospital, University Of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school | Recruiting | São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Repetitive Transcranial Magnetic Stimulation | Procedure | 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. |
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