Depressive Disorder, MajorPhase 2/3SELECT-TDCSNCT01033084
Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
A Phase 2/3 study testing transcranial direct current stimulation and Sertraline in people with Depressive Disorder, Major, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- transcranial direct current stimulation and Sertraline
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Dec 2011
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive Disorder, Major (SCID)
- HDRS > 18
Who cannot join
- Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
- Any axis II disorders.
- Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
- Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation
The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.
Read the detailed description
Major Depressive Disorder (MDD) is a common mental disorder, with a lifetime prevalence of 15% and an incidence of 5% per year. Its core symptoms include lack of pleasure in daily activities, thoughts of guilt and depressed mood. According to the World Health Organization, MDD is one of the ten most impairing conditions, leading to missing workdays, loss of quality of life and increasing expenses in health care. Besides, about 1% of patients with MDD complete suicide. Moreover, one third of patients with MDD remain depressed after more than two adequate treatments, i.e., they are refractory to conventional antidepressant treatments; also, most treated patients remain with residual symptoms. Therefore, the development of new treatments is necessary. Transcranial direct current stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct current is applied through the skull, with neurophysiologic studies showing that a considerable amount of electrical current reach the brain tissues, vis-à-vis the specified parameters. Thus, the DC could be applied over brain MDD-related areas, such as the dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment. Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However, it is necessary to replicate these findings in larger populations to increase the generalizability of the results and to verify the efficacy of the intervention. Our aim is to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD treatment, enrolling 120 eligible patients of both genders between 21-65 years not presenting active suicidal ideation. They will be allocated in 4 groups at random to receive active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks, measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to compare tDCMajor Depressive Disorder (MDD) is a common mental disorder, with a lifetime prevalence of 15% and an incidence of 5% per year. Its core symptoms include lack of pleasure in daily activities, thoughts of guilt and depressed mood. According to the World Health Organization, MDD is one of the ten most impairing conditions, leading to missing workdays, loss of quality of life and increasing expenses in health care. Besides, about 1% of patients with MDD complete suicide. Moreover, one third of patients with MDD remain depressed after more than two adequate treatments, i.e., they are refractory to conventional antidepressant treatments; also, most treated patients remain with residual symptoms. Therefore, the development of new treatments is necessary. Transcranial direct current stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct current is applied through the skull, with neurophysiologic studies showing that a considerable amount of electrical current reach the brain tissues, vis-à-vis the specified parameters. Thus, the DC could be applied over brain MDD-related areas, such as the dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment. Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However, it is necessary to replicate these findings in larger populations to increase the generalizability of the results and to verify the efficacy of the intervention. Our aim is to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD treatment, enrolling 120 eligible patients of both genders between 21-65 years not presenting active suicidal ideation. They will be allocated in 4 groups at random to receive active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks, measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to compare tDCS vs. sertraline and the association of sertraline and tDCS vs. each treatment alone in major depression treatment.
- Conditions
- Depressive Disorder, Major
- Being tested
- transcranial direct current stimulation, Sertraline, double placebo
- Keywords
- Depressive Disorder, Major
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6.
SertralineDrug
Patient will receive sertraline 50mg/day.
double placeboOther
double placebo arm (sham stimulation/placebo pill)
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation / sertraline | Experimental | In this arm, patients will receive sham stimulation and sertraline 50mg/day. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation. Receives: Drug: Sertraline |
| Sham stimulation / placebo pill | Sham comparator | Placebo pills are sugar pills having the same size and shape of the active pills.
In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation. Receives: Other: double placebo |
| Active stimulation / Sertraline | Experimental | In active 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.
Patients will receive Sertraline 50mg/day. Receives: Device: transcranial direct current stimulation; Drug: Sertraline |
| Active stimulation / placebo pill | Experimental | In active 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.
Placebo pills are sugar pills having the same size and shape of the active pill Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score
Measured: repeated-measures
Secondary outcomes (3)
HDRS-17 score at week 6.
Measured: week 6
Remission rate (MADRS<=10)
Measured: week 6
MADRS score
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Andre Brunoni, University of Sao Paulo
- Investigators
- Andre R Brunoni, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033084
- Sponsor's protocol ID
- USP-HU-001
- Other IDs
- FAPESP2009/05728-7
- Acronym
- SELECT-TDCS
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2009
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Vieira GP, Bueno VF, Goulart AC, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011 Jan;32(1):90-8. doi: 10.1016/j.cct.2010.09.007. Epub 2010 Sep 18.
PubMed 20854930Alessandra Baccaro, Andre Russowsky Brunoni, Isabela Martins Bensenor, Felipe Fregni. Hypomanic episode in unipolar depression during transcranial direct current stimulation. Acta Neuropsychiatrica 22(6):316-318, 2010.
Brunoni AR, Kemp AH, Dantas EM, Goulart AC, Nunes MA, Boggio PS, Mill JG, Lotufo PA, Fregni F, Bensenor IM. Heart rate variability is a trait marker of major depressive disorder: evidence from the sertraline vs. electric current therapy to treat depression clinical study. Int J Neuropsychopharmacol. 2013 Oct;16(9):1937-49. doi: 10.1017/S1461145713000497. Epub 2013 Jun 12.
PubMed 23759172Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.
PubMed 23389323
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT01033084
- Acronym / sponsor ID
- SELECT-TDCS / USP-HU-001
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Major
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Dec 2009 (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.
The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.
Detailed description
Major Depressive Disorder (MDD) is a common mental disorder, with a lifetime prevalence of 15% and an incidence of 5% per year. Its core symptoms include lack of pleasure in daily activities, thoughts of guilt and depressed mood. According to the World Health Organization, MDD is one of the ten most impairing conditions, leading to missing workdays, loss of quality of life and increasing expenses in health care. Besides, about 1% of patients with MDD complete suicide. Moreover, one third of patients with MDD remain depressed after more than two adequate treatments, i.e., they are refractory to conventional antidepressant treatments; also, most treated patients remain with residual symptoms. Therefore, the development of new treatments is necessary. Transcranial direct current stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct current is applied through the skull, with neurophysiologic studies showing that a considerable amount of electrical current reach the brain tissues, vis-à-vis the specified parameters. Thus, the DC could be applied over brain MDD-related areas, such as the dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment. Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However, it is necessary to replicate these findings in larger populations to increase the generalizability of the results and to verify the efficacy of the intervention. Our aim is to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD treatment, enrolling 120 eligible patients of both genders between 21-65 years not presenting active suicidal ideation. They will be allocated in 4 groups at random to receive active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks, measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to compare tDCMajor Depressive Disorder (MDD) is a common mental disorder, with a lifetime prevalence of 15% and an incidence of 5% per year. Its core symptoms include lack of pleasure in daily activities, thoughts of guilt and depressed mood. According to the World Health Organization, MDD is one of the ten most impairing conditions, leading to missing workdays, loss of quality of life and increasing expenses in health care. Besides, about 1% of patients with MDD complete suicide. Moreover, one third of patients with MDD remain depressed after more than two adequate treatments, i.e., they are refractory to conventional antidepressant treatments; also, most treated patients remain with residual symptoms. Therefore, the development of new treatments is necessary. Transcranial direct current stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct current is applied through the skull, with neurophysiologic studies showing that a considerable amount of electrical current reach the brain tissues, vis-à-vis the specified parameters. Thus, the DC could be applied over brain MDD-related areas, such as the dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment. Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However, it is necessary to replicate these findings in larger populations to increase the generalizability of the results and to verify the efficacy of the intervention. Our aim is to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD treatment, enrolling 120 eligible patients of both genders between 21-65 years not presenting active suicidal ideation. They will be allocated in 4 groups at random to receive active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks, measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to compare tDCS vs. sertraline and the association of sertraline and tDCS vs. each treatment alone in major depression treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation / sertraline | Experimental | Drug: SertralineIn this arm, patients will receive sham stimulation and sertraline 50mg/day. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation. |
| Sham stimulation / placebo pill | Sham comparator | Other: double placeboPlacebo pills are sugar pills having the same size and shape of the active pills. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation. |
| Active stimulation / Sertraline | Experimental | Device: transcranial direct current stimulation, Drug: SertralineIn active 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. Patients will receive Sertraline 50mg/day. |
| Active stimulation / placebo pill | Experimental | 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. 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. Placebo pills are sugar pills having the same size and shape of the active pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Depressive Disorder, Major (SCID)
- HDRS > 18
Key exclusion criteria (4 listed)
- Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
- Any axis II disorders.
- Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
- Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.
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 stimulationTranscranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6. | Device | Active stimulation / Sertraline, Active stimulation / placebo pill |
| SertralinePatient will receive sertraline 50mg/day. | Drug | Active stimulation / Sertraline, Sham stimulation / sertraline |
| double placebodouble placebo arm (sham stimulation/placebo pill) | Other | Sham stimulation / placebo pill |
Primary outcome
MADRS score
Time frame: repeated-measures
3 secondary outcomes
HDRS-17 score at week 6.
Time frame: week 6
Remission rate (MADRS<=10)
Time frame: week 6
MADRS score
Time frame: week 2
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 6 Dec 2011.
- Background: PubMed 20854930Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Vieira GP, Bueno VF, Goulart AC, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011 Jan;32(1):90-8. doi: 10.1016/j.cct.2010.09.007. Epub 2010 Sep 18.
- BackgroundAlessandra Baccaro, Andre Russowsky Brunoni, Isabela Martins Bensenor, Felipe Fregni. Hypomanic episode in unipolar depression during transcranial direct current stimulation. Acta Neuropsychiatrica 22(6):316-318, 2010.
- Derived from this study: PubMed 23759172Brunoni AR, Kemp AH, Dantas EM, Goulart AC, Nunes MA, Boggio PS, Mill JG, Lotufo PA, Fregni F, Bensenor IM. Heart rate variability is a trait marker of major depressive disorder: evidence from the sertraline vs. electric current therapy to treat depression clinical study. Int J Neuropsychopharmacol. 2013 Oct;16(9):1937-49. doi: 10.1017/S1461145713000497. Epub 2013 Jun 12.
- Derived from this study: PubMed 23389323Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.
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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.
Andre R Brunoni, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transcranial direct current stimulation and Sertraline in people with Depressive Disorder, Major, 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 2 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 6 Dec 2011. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MADRS score (time frame: repeated-measures). 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 NCT01033084, which also lists 4 linked publications.
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 6 Dec 2011.