DEPRESSION
Conditions
Keywords
TMS, elderly, depression, neuronavegation, neurocognition
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 of rTMS in elderly depressed patients.
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 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.
Interventions
PROCEDURETranscranial Magnetic Stimulation
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
PROCEDURERepetitive 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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 months | evaluation also by Geriatric Depression Scale (GDS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 months | recruting |
Countries
Brazil
Contacts
Primary ContactBianca B. Bellini
Backup ContactTMS Department
Outcome results
None listed