rTMS in Elderly Depressed:Neuronavegated Study

Phase 2

• Conditions: DEPRESSION
• Interventions: Procedure: Repetitive Transcranial Magnetic Stimulation; Procedure: Transcranial Magnetic Stimulation

• Registration Number: NCT01255072
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Status Verified: 2007-05
• Study Start: 2009-08
• Primary Completion: 2009-09
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS + placebo	Repetitive Transcranial Magnetic Stimulation	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.
SHAM	Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school; 🇧🇷 São Paulo, Brazil