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Clinical Trials/NCT01255072
NCT01255072
Unknown
Phase 2

Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study

University of Sao Paulo General Hospital1 site in 1 country40 target enrollmentAugust 2009
ConditionsDEPRESSION

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
DEPRESSION
Sponsor
University of Sao Paulo General Hospital
Enrollment
40
Locations
1
Primary Endpoint
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.
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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:
  • Hamilton Depression Rating Scale-17 items
  • Geriatric Depression Scale (GDS)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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)

Study Sites (1)

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