NCT01255072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 30, 2011

Status Verified

May 1, 2007

Enrollment Period

1 month

First QC Date

December 3, 2010

Last Update Submit

June 29, 2011

Conditions

DEPRESSION

Keywords

TMSelderlydepressionneuronavegationneurocognition

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 months

Secondary Outcomes (1)

  • 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 Arms (2)

Active rTMS + placebo

ACTIVE COMPARATOR

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

SHAM

SHAM COMPARATOR

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

Interventions

Transcranial Magnetic StimulationPROCEDURE

20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.

Also known as: Sham TMS
SHAM
Repetitive Transcranial Magnetic StimulationPROCEDURE

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.

Also known as: TMS
Active rTMS + placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Bianca B. Bellini

    Department and Institute os Psychiatry, General Hospital, University Of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca B. Bellini

CONTACT

+5511 30698159bellinibianca@yahoo.com.br

TMS Department

CONTACT

+5511 30698159emt@hcnet.usp.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 7, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2011

Last Updated

June 30, 2011

Record last verified: 2007-05

Locations

BR(1)