rTMS in Elderly Depressed:Neuronavegated Study

DEPRESSION Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255072
• Other study ID #: BBellini - 0996/07
• Status: Recruiting
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: June 29, 2011
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2007
• Source: University of Sao Paulo General Hospital
• Contact: Bianca B. Bellini
• Phone: +5511 30698159
• Email: bellinibianca[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• DEPRESSION

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	30 months	No