Major Depressive Disorder 1Phase 2NCT01525524
Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation
A Phase 2 study testing Transcranial Direct Current Stimulation in people with Major Depressive Disorder 1, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Major Depressive Disorder 1
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder after stroke
- First episode of Stroke
- Hamilton > 17
Who cannot join
- Others severe neurologic conditions
- Others Axis I besides anxiety
- Important suicidal ideation
- Use of antidepressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial
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.
Read the detailed description
The Study of Morbidity and Mortality of stroke (EMMA) is a cohort study of patients with stroke.
- Conditions
- Major Depressive Disorder 1
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, Major Depression, Stroke
- Medical subject headings
- Major Depressive Disorder 1, Depressive Disorder, Major, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called Transcranial Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Active Stimulation | Active comparator | 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Hamilton of active will be lower than sham group
Measured: Week 4 after tenth day of tDCS
Secondary outcomes (1)
Treatment response
Response is defined as less than 50% of baseline Hamilton
Measured: Week 4 after tenth day of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder 1Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Valiengo, University of Sao Paulo
- Investigators
- Leandro Valiengo, MD, Principal investigator, HU-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525524
- Sponsor's protocol ID
- 1180/12
- Status last verified
- Sep 2014
- First submitted
- 24 Jan 2012
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27815324
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT01525524
- Acronym / sponsor ID
- 1180/12
- Conditions
- Major Depressive Disorder 1
- Keywords
- tDCS, Major Depression, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: Transcranial Direct Current StimulationIn 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. |
| Active Stimulation | Active comparator | Device: Transcranial Direct Current StimulationIn 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major Depressive Disorder after stroke
- First episode of Stroke
- Hamilton > 17
Key exclusion criteria (4 listed)
- Others severe neurologic conditions
- Others Axis I besides anxiety
- Important suicidal ideation
- Use of antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: Transcranial StimulationIn 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. | Device | Active Stimulation, Sham Stimulation |
Primary outcome
Treatment response
Time frame: Week 4 after tenth day of tDCS
Hamilton of active will be lower than sham group
1 secondary outcome
Treatment response
Time frame: Week 4 after tenth day of tDCS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Derived from this study: PubMed 27815324Valiengo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leandro Valiengo, MD principal investigator
HU-USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Direct Current Stimulation in people with Major Depressive Disorder 1, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: Week 4 after tenth day of tDCS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.