rTMS in Elderly Depressed:Neuronavegated Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study

Conditions
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DEPRESSION

Intervention / Treatment
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* Procedure: Transcranial Magnetic Stimulation
* Procedure: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active rTMS + placebo<br>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<br>* 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.<br>* Other names: TMS;|
| Sham Comparator: SHAM<br>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<br>* 20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.<br>* Other names: Sham TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, elderly, depression, neuronavegation, neurocognition