rTMS in Elderly Depressed:Neuronavegated Study

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: DEPRESSION

Treatments: Procedure: Transcranial Magnetic Stimulation; Procedure: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01255072

BBellini - 0996/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active rTMS + placebo

Active Comparator group

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.

Treatment:

Procedure: Repetitive Transcranial Magnetic Stimulation

SHAM

Sham Comparator group

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.

Treatment:

Procedure: Transcranial Magnetic Stimulation