Convulsion, Non-EpilepticPhase 4NEST-T_1NCT00835627
Treatment Trial for Psychogenic Nonepileptic Seizures
A Phase 4 study testing sertraline, CBT-ip and Combined (sertraline + CBT-ip) in people with Convulsion, Non-Epileptic and Conversion Disorder, run by Rhode Island Hospital at 3 sites in United States.
Trial summary
The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Convulsion, Non-Epileptic, Conversion Disorder, Depression
- What is being tested?
- sertraline, CBT-ip and Combined (sertraline + CBT-ip)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Jun 2013
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Video electroencephalogram (EEG) confirmed diagnosis of NES
- Have at least one nonepileptic seizure per month
- Able to complete self report symptom scales
- Not receiving optimized sertraline
Who cannot join
- Equivocal EEG findings
- using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
- allergy/sensitivity to sertraline
- current alcohol/drug dependence
- serious medical illness requiring current hospitalization
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Rhode Island Hospital
Providence, Rhode Island, 02903
Stanford University
Stanford, California, 94305
About this study
Official title: Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures
The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.
Read the detailed description
This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip) or community care (treatment as usual TAU). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.
After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be randomized to either: flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU. Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. Those randomized to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow with their treatment providers.
After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning.
Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary to evaluate their daily seizure activity.
- Conditions
- Convulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Dissociative Disorders
- Being tested
- sertraline, CBT-ip, Combined (sertraline + CBT-ip), Standard Care
- Keywords
- Treatment, Cognitive Behavior Therapy, pharmacotherapy, psychogenic nonepileptic seizures, pseudoseizures, dissociative seizures, conversion disorder
- Medical subject headings
- Seizures, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Dissociative Disorders, Psychogenic Nonepileptic Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloft
flexible dose sertraline
CBT-ipBehavioural
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions
Combined (sertraline + CBT-ip)Other
Also called Zoloft, CBT-ip
flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions
Standard CareOther
Also called TAU, standard care
community care, treatment as usual: routine follow up with existing providers
| Study group | Role | What they receive |
|---|---|---|
| sertraline | Active comparator | flexible dose sertraline Receives: Drug: sertraline |
| CBT-ip | Active comparator | cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions Receives: Behavioral: CBT-ip |
| Combined (sertraline + CBT-ip) | Active comparator | flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions Receives: Other: Combined (sertraline + CBT-ip) |
| Standard care | Active comparator | community care / treatment as usual: routine follow up with existing providers Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure frequency
Measured: weekly
Secondary outcomes (3)
Identify predictors of response from the following 3 groups: clinical diagnoses
Measured: baseline
psychological symptoms
Measured: bi-weekly
socio-demographic variables
Measured: bi-weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Convulsion, Non-EpilepticStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Epilepsy Society, Epilepsy Foundation, University of Cincinnati, Stanford University
- Responsible party
- Principal investigator, W. Curt LaFrance Jr., M.D., Rhode Island Hospital
- Investigators
- W. Curt LaFrance, Jr., MD, MPH, Principal investigator, Rhode Island Hospital / Brown Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835627
- Sponsor's protocol ID
- EF122982
- Acronym
- NEST-T_1
- Status last verified
- Nov 2014
- First submitted
- 30 Jan 2009
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. doi: 10.1212/wnl.58.6.990. No abstract available.
PubMed 11914432LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. doi: 10.1016/s1525-5069(02)00505-4.
PubMed 12609316LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.
PubMed 15186340LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.
PubMed 16150653LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.
PubMed 16540377LaFrance WC Jr. Use of serum prolactin in diagnosing epileptic seizures: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2006 Apr 25;66(8):1287-8; author reply 1287-8. doi: 10.1212/01.wnl.0000222496.94195.14. No abstract available.
PubMed 16636265LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. doi: 10.1212/01.wnl.0000224953.94807.be. No abstract available.
PubMed 16769930LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.
PubMed 18070841LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. doi: 10.1016/j.yebeh.2007.12.017. Epub 2008 Feb 20.
PubMed 18282812LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.
PubMed 18317280LaFrance WC Jr, Baker GA, Duncan R, Goldstein LH, Reuber M. Minimum requirements for the diagnosis of psychogenic nonepileptic seizures: a staged approach: a report from the International League Against Epilepsy Nonepileptic Seizures Task Force. Epilepsia. 2013 Nov;54(11):2005-18. doi: 10.1111/epi.12356. Epub 2013 Sep 20.
PubMed 24111933LaFrance WC Jr, Reuber M, Goldstein LH. Management of psychogenic nonepileptic seizures. Epilepsia. 2013 Mar;54 Suppl 1:53-67. doi: 10.1111/epi.12106.
PubMed 23458467LaFrance WC Jr, Deluca M, Machan JT, Fava JL. Traumatic brain injury and psychogenic nonepileptic seizures yield worse outcomes. Epilepsia. 2013 Apr;54(4):718-25. doi: 10.1111/epi.12053. Epub 2013 Jan 2.
PubMed 23281644LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.
PubMed 21299547LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817.
PubMed 24989152
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures
- ClinicalTrials.gov ID
- NCT00835627
- Acronym / sponsor ID
- NEST-T_1 / EF122982
- Conditions
- Convulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Dissociative Disorders
- Keywords
- Treatment, Cognitive Behavior Therapy, pharmacotherapy, psychogenic nonepileptic seizures, pseudoseizures, dissociative seizures, conversion disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- American Epilepsy Society, Epilepsy Foundation, University of Cincinnati, Stanford University
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Feb 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 investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.
Detailed description
This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip) or community care (treatment as usual TAU). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.
After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be randomized to either: flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU. Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. Those randomized to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow with their treatment providers.
After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning.
Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary to evaluate their daily seizure activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sertraline | Active comparator | Drug: sertralineflexible dose sertraline |
| CBT-ip | Active comparator | Behavioral: CBT-ipcognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions |
| Combined (sertraline + CBT-ip) | Active comparator | Other: Combined (sertraline + CBT-ip)flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions |
| Standard care | Active comparator | Other: Standard Carecommunity care / treatment as usual: routine follow up with existing providers |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Video electroencephalogram (EEG) confirmed diagnosis of NES
- Have at least one nonepileptic seizure per month
- Able to complete self report symptom scales
- Not receiving optimized sertraline
Key exclusion criteria (5 listed)
- Equivocal EEG findings
- using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
- allergy/sensitivity to sertraline
- current alcohol/drug dependence
- serious medical illness requiring current hospitalization
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 |
|---|---|---|
| sertralineAlso: Zoloftflexible dose sertraline | Drug | sertraline |
| CBT-ipcognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions | Behavioural | CBT-ip |
| Combined (sertraline + CBT-ip)Also: Zoloft, CBT-ipflexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions | Other | Combined (sertraline + CBT-ip) |
| Standard CareAlso: TAU, standard carecommunity care, treatment as usual: routine follow up with existing providers | Other | Standard care |
Primary outcome
seizure frequency
Time frame: weekly
3 secondary outcomes
Identify predictors of response from the following 3 groups: clinical diagnoses
Time frame: baseline
psychological symptoms
Time frame: bi-weekly
socio-demographic variables
Time frame: bi-weekly
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 10 Nov 2014.
- Background: PubMed 11914432LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. doi: 10.1212/wnl.58.6.990. No abstract available.
- Background: PubMed 12609316LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. doi: 10.1016/s1525-5069(02)00505-4.
- Background: PubMed 15186340LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.
- Background: PubMed 16150653LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.
- Background: PubMed 16540377LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.
- Background: PubMed 16636265LaFrance WC Jr. Use of serum prolactin in diagnosing epileptic seizures: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2006 Apr 25;66(8):1287-8; author reply 1287-8. doi: 10.1212/01.wnl.0000222496.94195.14. No abstract available.
- Background: PubMed 16769930LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. doi: 10.1212/01.wnl.0000224953.94807.be. No abstract available.
- Background: PubMed 18070841LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.
- Background: PubMed 18282812LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. doi: 10.1016/j.yebeh.2007.12.017. Epub 2008 Feb 20.
- Background: PubMed 18317280LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.
- Background: PubMed 24111933LaFrance WC Jr, Baker GA, Duncan R, Goldstein LH, Reuber M. Minimum requirements for the diagnosis of psychogenic nonepileptic seizures: a staged approach: a report from the International League Against Epilepsy Nonepileptic Seizures Task Force. Epilepsia. 2013 Nov;54(11):2005-18. doi: 10.1111/epi.12356. Epub 2013 Sep 20.
- Background: PubMed 23458467LaFrance WC Jr, Reuber M, Goldstein LH. Management of psychogenic nonepileptic seizures. Epilepsia. 2013 Mar;54 Suppl 1:53-67. doi: 10.1111/epi.12106.
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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.
W. Curt LaFrance, Jr., MD, MPH principal investigator
Rhode Island Hospital / Brown Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline, CBT-ip and Combined (sertraline + CBT-ip) in people with Convulsion, Non-Epileptic and Conversion Disorder, run by Rhode Island Hospital at 3 sites in United States.
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 5 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
seizure frequency (time frame: weekly). 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 NCT00835627, which also lists 15 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 10 Nov 2014.