Clinical trial NCT01255072: rTMS in Elderly Depressed:Neuronavegated Study
Official title: Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: DEPRESSION
Keywords: TMS
elderly
depression
neuronavegation
neurocognition
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: 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.
timeFrame: 30 months
Secondary outcomes:
measure: 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.
timeFrame: 30 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
Study officials:
affiliation: Department and Institute os Psychiatry, General Hospital, University Of São Paulo
name: Bianca B. Bellini
role: PRINCIPAL_INVESTIGATOR
References: