Transcranial Direct Current StimulationPhase 2NCT01623726
Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia
A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Schizophrenia
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with age between 18-59 years
- diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist
- baseline score higher than 20 for negative symptoms at PAAN
- patients able to read and understand Portuguese.
Who cannot join
- other psychiatric diagnosis
- criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders
- presence of other severe neurological or clinical diseases
- presence of suicidal behavior (planning or attempt in the previous 4 weeks)
- pregnancy
- incapacity of coping with the informed consent
- specific tDCS limitations (such as anatomic problems)
- Regarding medication: all patients should have stable dosology of medications for at least 6 weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atenção Integrada à Saúde Mental
São Paulo, São Paulo, 01415001
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial
The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.
Read the detailed description
Overview
The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Transcranial Direct Current Stimulation, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Procedure or surgery
Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.
| Study group | Role | What they receive |
|---|---|---|
| tDCS active | Experimental | Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes. Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
| tDCS sham | Placebo comparator | Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Symptoms Rates as assessed by the PAANS
Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores
Measured: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)
Secondary outcomes (4)
Mental Mini Exam
cognitive evaluation as assessed by the Mental Mini Exam
Measured: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam
Moca rating Scale
comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test
Measured: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test
Stroop Victoria
comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria
Measured: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version
Neuropsychological Assessment
comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool
Measured: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: To be submitted for grant application
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Brunoni, University of Sao Paulo
- Investigators
- Andre R Brunoni, PhD, Study chair, Irmandade da Santa Casa de Misericórdia de São PauloPedro Shiozawa, MD, Principal investigator, Irmandade da Santa Casa de Misericóridia de São PauloQuirino Jr Cordeiro, PhD, Study director, Irmandade da Santa Casa de Misericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623726
- Sponsor's protocol ID
- CAISM-001
- Status last verified
- Dec 2013
- First submitted
- 8 Jun 2012
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Loranger AW. Sex difference in age at onset of schizophrenia. Arch Gen Psychiatry. 1984 Feb;41(2):157-61. doi: 10.1001/archpsyc.1984.01790130053007.
PubMed 6696597Andrade L, Caraveo-Anduaga JJ, Berglund P, Bijl RV, De Graaf R, Vollebergh W, Dragomirecka E, Kohn R, Keller M, Kessler RC, Kawakami N, Kilic C, Offord D, Ustun TB, Wittchen HU. The epidemiology of major depressive episodes: results from the International Consortium of Psychiatric Epidemiology (ICPE) Surveys. Int J Methods Psychiatr Res. 2003;12(1):3-21. doi: 10.1002/mpr.138.
PubMed 12830306McGlashan TH, Johannessen JO. Early detection and intervention with schizophrenia: rationale. Schizophr Bull. 1996;22(2):201-22. doi: 10.1093/schbul/22.2.201.
PubMed 8782282Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet. 1995 Aug 19;346(8973):477-81. doi: 10.1016/s0140-6736(95)91325-4. No abstract available.
PubMed 7637483Bressan RA, Chaves AC, Pilowsky LS, Shirakawa I, Mari JJ. Depressive episodes in stable schizophrenia: critical evaluation of the DSM-IV and ICD-10 diagnostic criteria. Psychiatry Res. 2003 Jan 25;117(1):47-56. doi: 10.1016/s0165-1781(02)00298-6.
PubMed 12581820Bensenor IM, Brunoni AR, Pilan LA, Goulart AC, Busatto GF, Lotufo PA, Scazufca M, Menezes PR. Cardiovascular risk factors in patients with first-episode psychosis in Sao Paulo, Brazil. Gen Hosp Psychiatry. 2012 May-Jun;34(3):268-75. doi: 10.1016/j.genhosppsych.2011.12.010. Epub 2012 Feb 2.
PubMed 22305369Awad AG, Voruganti LN. The burden of schizophrenia on caregivers: a review. Pharmacoeconomics. 2008;26(2):149-62. doi: 10.2165/00019053-200826020-00005.
PubMed 18198934Brunoni AR, Teng CT, Correa C, Imamura M, Brasil-Neto JP, Boechat R, Rosa M, Caramelli P, Cohen R, Del Porto JA, Boggio PS, Fregni F. Neuromodulation approaches for the treatment of major depression: challenges and recommendations from a working group meeting. Arq Neuropsiquiatr. 2010 Jun;68(3):433-51. doi: 10.1590/s0004-282x2010000300021.
PubMed 20602051BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386Davey NJ, Smith HC, Savic G, Maskill DW, Ellaway PH, Frankel HL. Comparison of input-output patterns in the corticospinal system of normal subjects and incomplete spinal cord injured patients. Exp Brain Res. 1999 Aug;127(4):382-90. doi: 10.1007/s002210050806.
PubMed 10480273Brunoni AR, Ferrucci R, Fregni F, Boggio PS, Priori A. Transcranial direct current stimulation for the treatment of major depressive disorder: a summary of preclinical, clinical and translational findings. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Oct 1;39(1):9-16. doi: 10.1016/j.pnpbp.2012.05.016. Epub 2012 May 28.
PubMed 22651961Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.
PubMed 17559710Wagner T, Fregni F, Fecteau S, Grodzinsky A, Zahn M, Pascual-Leone A. Transcranial direct current stimulation: a computer-based human model study. Neuroimage. 2007 Apr 15;35(3):1113-24. doi: 10.1016/j.neuroimage.2007.01.027. Epub 2007 Feb 4.
PubMed 17337213Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.
PubMed 19348793
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01623726
- Acronym / sponsor ID
- CAISM-001
- Keywords
- Transcranial Direct Current Stimulation, Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To be submitted for grant application
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 20 Jun 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.
The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.
Detailed description
Overview
The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS active | Experimental | Procedure: Transcranial Direct Current Stimulation (tDCS)Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes. |
| tDCS sham | Placebo comparator | Procedure: Transcranial Direct Current Stimulation (tDCS)Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with age between 18-59 years
- diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist
- baseline score higher than 20 for negative symptoms at PAAN
- patients able to read and understand Portuguese.
Key exclusion criteria (8 listed)
- other psychiatric diagnosis
- criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders
- presence of other severe neurological or clinical diseases
- presence of suicidal behavior (planning or attempt in the previous 4 weeks)
- pregnancy
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 Stimulation (tDCS)Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA. | Procedure or surgery | tDCS active, tDCS sham |
Primary outcome
Negative Symptoms Rates as assessed by the PAANS
Time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)
Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores
4 secondary outcomes
Mental Mini Exam
Time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam
Moca rating Scale
Time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test
Stroop Victoria
Time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version
Neuropsychological Assessment
Time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 6696597Loranger AW. Sex difference in age at onset of schizophrenia. Arch Gen Psychiatry. 1984 Feb;41(2):157-61. doi: 10.1001/archpsyc.1984.01790130053007.
- Background: PubMed 12830306Andrade L, Caraveo-Anduaga JJ, Berglund P, Bijl RV, De Graaf R, Vollebergh W, Dragomirecka E, Kohn R, Keller M, Kessler RC, Kawakami N, Kilic C, Offord D, Ustun TB, Wittchen HU. The epidemiology of major depressive episodes: results from the International Consortium of Psychiatric Epidemiology (ICPE) Surveys. Int J Methods Psychiatr Res. 2003;12(1):3-21. doi: 10.1002/mpr.138.
- Background: PubMed 8782282McGlashan TH, Johannessen JO. Early detection and intervention with schizophrenia: rationale. Schizophr Bull. 1996;22(2):201-22. doi: 10.1093/schbul/22.2.201.
- Background: PubMed 7637483Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet. 1995 Aug 19;346(8973):477-81. doi: 10.1016/s0140-6736(95)91325-4. No abstract available.
- Background: PubMed 12581820Bressan RA, Chaves AC, Pilowsky LS, Shirakawa I, Mari JJ. Depressive episodes in stable schizophrenia: critical evaluation of the DSM-IV and ICD-10 diagnostic criteria. Psychiatry Res. 2003 Jan 25;117(1):47-56. doi: 10.1016/s0165-1781(02)00298-6.
- Background: PubMed 22305369Bensenor IM, Brunoni AR, Pilan LA, Goulart AC, Busatto GF, Lotufo PA, Scazufca M, Menezes PR. Cardiovascular risk factors in patients with first-episode psychosis in Sao Paulo, Brazil. Gen Hosp Psychiatry. 2012 May-Jun;34(3):268-75. doi: 10.1016/j.genhosppsych.2011.12.010. Epub 2012 Feb 2.
- Background: PubMed 18198934Awad AG, Voruganti LN. The burden of schizophrenia on caregivers: a review. Pharmacoeconomics. 2008;26(2):149-62. doi: 10.2165/00019053-200826020-00005.
- Background: PubMed 20602051Brunoni AR, Teng CT, Correa C, Imamura M, Brasil-Neto JP, Boechat R, Rosa M, Caramelli P, Cohen R, Del Porto JA, Boggio PS, Fregni F. Neuromodulation approaches for the treatment of major depression: challenges and recommendations from a working group meeting. Arq Neuropsiquiatr. 2010 Jun;68(3):433-51. doi: 10.1590/s0004-282x2010000300021.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 20633386Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
- Background: PubMed 10480273Davey NJ, Smith HC, Savic G, Maskill DW, Ellaway PH, Frankel HL. Comparison of input-output patterns in the corticospinal system of normal subjects and incomplete spinal cord injured patients. Exp Brain Res. 1999 Aug;127(4):382-90. doi: 10.1007/s002210050806.
- Background: PubMed 22651961Brunoni AR, Ferrucci R, Fregni F, Boggio PS, Priori A. Transcranial direct current stimulation for the treatment of major depressive disorder: a summary of preclinical, clinical and translational findings. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Oct 1;39(1):9-16. doi: 10.1016/j.pnpbp.2012.05.016. Epub 2012 May 28.
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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, PhD study chair
Irmandade da Santa Casa de Misericórdia de São Paulo
Pedro Shiozawa, MD principal investigator
Irmandade da Santa Casa de Misericóridia de São Paulo
Quirino Jr Cordeiro, PhD study director
Irmandade da Santa Casa de Misericórdia de São 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 study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Schizophrenia, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 Dec 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Negative Symptoms Rates as assessed by the PAANS (time frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)). 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 NCT01623726, which also lists 16 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 16 Dec 2013.