rTMS in Elderly Depressed:Neuronavegated Study

June 29, 2011 updated by: University of Sao Paulo General Hospital

Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active rTMS + placebo
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
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.
Other Names:
  • TMS
SHAM_COMPARATOR: SHAM
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
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Other Names:
  • Sham TMS

What is the study measuring?

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.
Time Frame: 30 months
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.
Time Frame: 30 months
recruting
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Bianca B. Bellini, Department and Institute os Psychiatry, General Hospital, University Of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBellini - 0996/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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