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rTMS in Elderly Depressed:Neuronavegated Study

Primary Purpose

DEPRESSION

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DEPRESSION focused on measuring TMS, elderly, depression, neuronavegation, neurocognition

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS + placebo

SHAM

Arm Description

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.

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.

Outcomes

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.
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.
recruting

Full Information

First Posted
December 3, 2010
Last Updated
June 29, 2011
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01255072
Brief Title
rTMS in Elderly Depressed:Neuronavegated Study
Official Title
Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DEPRESSION
Keywords
TMS, elderly, depression, neuronavegation, neurocognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS + placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SHAM
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
Sham TMS
Intervention Description
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Intervention Type
Procedure
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
evaluation also by Geriatric Depression Scale (GDS)
Time Frame
30 months
Secondary Outcome Measure Information:
Title
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.
Description
recruting
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca B. Bellini
Phone
+5511 30698159
Email
bellinibianca@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
TMS Department
Phone
+5511 30698159
Email
emt@hcnet.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca B. Bellini
Organizational Affiliation
Department and Institute os Psychiatry, General Hospital, University Of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TMS Department
Phone
+5511 3069 8159
Email
emt@hcnet.usp.br

12. IPD Sharing Statement

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rTMS in Elderly Depressed:Neuronavegated Study

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