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Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation

Primary Purpose

Major Depressive Disorder 1

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder 1 focused on measuring tDCS, Major Depression, Stroke

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham Stimulation

Active Stimulation

Arm Description

In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the Transcranial Direct Current Stimulation. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 29 minutes.

In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the transcranial Direct Current Stimulation device. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 30 minutes.

Outcomes

Primary Outcome Measures

Treatment response
Hamilton of active will be lower than sham group

Secondary Outcome Measures

Treatment response
Response is defined as less than 50% of baseline Hamilton

Full Information

First Posted
January 24, 2012
Last Updated
September 7, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01525524
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder 1
Keywords
tDCS, Major Depression, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the Transcranial Direct Current Stimulation. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 29 minutes.
Arm Title
Active Stimulation
Arm Type
Active Comparator
Arm Description
In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the transcranial Direct Current Stimulation device. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 30 minutes.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Transcranial Stimulation
Intervention Description
In active stimulation(active Transcranial Direct Current Stimulation), the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
Primary Outcome Measure Information:
Title
Treatment response
Description
Hamilton of active will be lower than sham group
Time Frame
Week 4 after tenth day of tDCS
Secondary Outcome Measure Information:
Title
Treatment response
Description
Response is defined as less than 50% of baseline Hamilton
Time Frame
Week 4 after tenth day of tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leandro Valiengo, MD
Organizational Affiliation
HU-USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27815324
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.
Results Reference
derived

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Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation

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