Clinical trial NCT01525524: Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation
Official title: Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder 1
Keywords: tDCS
Major Depression
Stroke
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the main public health problems in America Latina. It can be associated with several neuropsychiatric complications, which include a broad spectrum of emotional distress and cognitive, results in important clinical implications for the prognosis of these patients. Depression is a common complication, affecting around 5-72% of patients and is associated with various cognitive deficits and also with increased mortality - up to 50% more deaths compared to non-depressed patients. Treatment of depression after stroke is important not only to improve depressive symptoms but can also be beneficial for cognitive deficits, activities of daily living. and leads to increased survival for these patients. There are different treatments for depression after stroke, all showing inconclusive results, even though antidepressants have been effective in some groups of patients, tolerability and treatment adherence were not very good-so it is necessary that new therapeutic modalities are presented with good tolerability. In this sense, transcranial direct current stimulation (tDCS) is an interesting technique that can provide interesting results, which proved to be effective for depression in some studies. This study proposes to investigate the effect of tDCS for the treatment of major depressive disorder after stroke. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study in a subsample of participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke. They will be allocated to one of the groups: sham or active tDCS group. Participants will receive ten consecutive days of active or sham stimulation and return at the end of two weeks to evaluate the improvement in depression, cognition and functionality. As objectives, the investigators expect to see a clinical improvement of depression through scales like Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam), FAB (frontal assessment battery) and trail test. Another goal is to see improvement in markers related to depression as BDNF, cortisol, interleukins and heart rate variability. With all this, the investigators hope to offer a new treatment, and effective with few side effects to treat depression after stroke.

Detailed description: The Study of Morbidity and Mortality of stroke (EMMA) is a cohort study of patients with stroke.

Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder after stroke
* First episode of Stroke
* Hamilton \> 17

Exclusion Criteria:

* Others severe neurologic conditions
* Others Axis I besides anxiety
* Important suicidal ideation
* Use of antidepressants

Primary outcomes:
measure: Treatment response
timeFrame: Week 4 after tenth day of tDCS
Secondary outcomes:
measure: Treatment response
timeFrame: Week 4 after tenth day of tDCS
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: HU-USP
name: Leandro Valiengo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valiengo LC, Goulart AC, de Oliveira JF, Bensenor IM, Lotufo PA, Brunoni AR. Transcranial direct current stimulation for the treatment of post-stroke depression: results from a randomised, sham-controlled, double-blinded trial. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):170-175. doi: 10.1136/jnnp-2016-314075. Epub 2016 Nov 4.