rTMS in Elderly Depressed:Neuronavegated Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01255072
First received: December 3, 2010
Last updated: June 29, 2011
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
DEPRESSION
Procedure: Transcranial Magnetic Stimulation
Procedure: Repetitive Transcranial Magnetic Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    evaluation also by Geriatric Depression Scale (GDS)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    recruting


Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sham TMS

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255072

Contacts
Contact: Bianca B. Bellini +5511 30698159 bellinibianca@yahoo.com.br
Contact: TMS Department +5511 30698159 emt@hcnet.usp.br

Locations
Brazil
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school Recruiting
São Paulo, Brazil
Contact: TMS Department    +5511 3069 8159    emt@hcnet.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Bianca B. Bellini Department and Institute os Psychiatry, General Hospital, University Of São Paulo
  More Information

No publications provided

Responsible Party: Bianca Boura Bellini, Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
ClinicalTrials.gov Identifier: NCT01255072     History of Changes
Other Study ID Numbers: BBellini - 0996/07
Study First Received: December 3, 2010
Last Updated: June 29, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
TMS
elderly
depression
neuronavegation
neurocognition

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014