OCDNCT02500888
Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder
A study testing Radiosurgery in people with OCD and Quality of Life, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- OCD, Quality of Life
- What is being tested?
- Radiosurgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2015to 30 Jun 2022
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OCD diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a major disease entity. If comorbidity with other psychiatric or personality disorders, OCD symptoms dominate the clinical picture and precede other disorders.
- Duration of OCD symptoms of at least five years.
- Scores range of the obsessive-compulsive symptoms "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) greater than 26 (or greater than 13, if obsessions or compulsions alone).
- Fill up the criteria for refractory to prior treatments.
- Be accepted by the method of "best estimate" for defining the patient is refractory, which consisted of confirmation by at least two specialists obsessive-compulsive disorder that the patient fulfills the criteria for effective refractory to previous treatments.
Who cannot join
- History of head trauma or post-traumatic amnesia.
- Background of systemic or neurological diseases with brain impairment, severe and active.
- History of current use of substances capable of inducing psychopathological manifestations, or signs of cumulative effects of alcohol or drugs in the central nervous system (such as cortical atrophy), confirmed by neuroimaging.
- pregnancy or lactation.
- Refusal to submit to the radiosurgical procedure.
- Refusal to accept the informed consent form, or participate.
- History of mental retardation and / or inability to understand the informed consent, confirmed by neuropsychological tests of the initial evaluation.
- Lack of family or companion with proper capacity of understanding of the informed consent in patients with comorbid major depression or psychosis that could potentially have difficulty performing the appropriate judgment as to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Paulo Abreu, M.D.; Ph.D., 555133598294, paulo.abreu@ufrgs.br
Marcelo Sousa, M.D.; M.Sc., 555199557634, mbsousa@hcpa.edu.br
About this study
Official title: Initial Evaluation of Efficacy and Adverse Events of Single Lesions in Bilateral Ventral-capsular and Ventral Capsulotomy-striatal by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder
The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.
Read the detailed description
About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging studies.
- Conditions
- OCD, Quality of Life
- Being tested
- Radiosurgery
- Keywords
- OCD, Neurosurgery, Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiosurgeryRadiation
Only one radiation session of about 180 Gy in bilateral internal capsule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Radiosurgery by linear accelerator. Receives: Radiation: Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OCD symptoms
Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale
Measured: Every 3 months until 12 months
Secondary outcomes (11)
Change in quality of life.
Application of "Medical Outcomes Study 36-Item Short-Form Health Survey" (SF-36) scale
Measured: Every 3 months until 12 months
Change in brain-derived neurotrophic factor (BDNF) blood dosing
Serological blood tests
Measured: 12 months
Change in psychological tests
Application of:
- Mini Mental Modified (3MS) test
- Wechsler of intelligence test
- Stroop of colors test
- Tracks tests A and B
- Boston Naming Test (BNT)
- Wechsler Memory Scale Revised (WMS-R)
- Wisconsin (WCST) test
- Brief Visual Memory Test (BVLT)
- Hopkins Verbal Learning Test (HBLT) test
- Benton Line Orientation (BLO) test
- Grooved Pegboard Test
- Finger Tapping test
- Complex figure of Rey test
Measured: 12 months
Side effects and complications
Application of "Systematic Assessment for Treatment Emergent Effects" (SAFTEE) Event List and Interview.
Measured: Every 3 months until 12 months
Change in familial accommodation
Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS)
Measured: Every 3 months until 12 months
Change in anxiety symptoms.
Application of "Beck Anxiety Inventory" (BAI) scale
Measured: Every 3 months until 12 months
Change in depressive symptoms.
Application of "Beck Depression Inventory" (BDI) scale
Measured: Every 3 months until 12 months
Change in near-infrared spectroscopy (NIRS) brain blood flow
During application of Stroop psychological test.
Measured: 12 months
Change in OCD symptoms by CPRS
Application of "Comprehensive Psychopathological Rating Scale" (CPRS)
Measured: Every 3 months
Change in OCD symptoms by NIMH.
Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale)
Measured: Every 3 months
Change in Global Functioning
Application of "Global Assessment of Functioning Scale" (GAF)
Measured: Every 3 months until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start30 Jun 2015
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Abreu, M.D.; Ph.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500888
- Sponsor's protocol ID
- 14-0341
- Status last verified
- Feb 2021
- First submitted
- 9 Jul 2015
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Asberg M, Montgomery SA, Perris C, Schalling D, Sedvall G. A comprehensive psychopathological rating scale. Acta Psychiatr Scand Suppl. 1978;(271):5-27. doi: 10.1111/j.1600-0447.1978.tb02357.x. No abstract available.
PubMed 277059Ballantine HT Jr, Cassidy WL, Flanagan NB, Marino R Jr. Stereotaxic anterior cingulotomy for neuropsychiatric illness and intractable pain. J Neurosurg. 1967 May;26(5):488-95. doi: 10.3171/jns.1967.26.5.0488. No abstract available.
PubMed 5337782Batistuzzo MC, Taub A, Nakano E, D'Alcante CC, de Mathis ME, Hoexter MQ, Miguel EC, Lopes AC. Performance of patients with refractory obsessive-compulsive disorder in the Frontal Systems Behavior Scale. Neurocase. 2009;15(2):157-62. doi: 10.1080/13554790802709047. Epub 2009 Mar 9.
PubMed 19274575Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199BECK 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 13688369Brandt RA, Salvajoli JV, Oliveira VC, Carmignani M, da Cruz JC, Leal HD, Ferraz L. [Linear accelerator radiosurgery]. Arq Neuropsiquiatr. 1995 Mar;53(1):38-45. doi: 10.1590/s0004-282x1995000100007. Portuguese.
PubMed 7575207Calvocoressi L, Libman D, Vegso SJ, McDougle CJ, Price LH. Global functioning of inpatients with obsessive-compulsive disorder, schizophrenia, and major depression. Psychiatr Serv. 1998 Mar;49(3):379-81. doi: 10.1176/ps.49.3.379.
PubMed 9525801Calvocoressi L, Mazure CM, Kasl SV, Skolnick J, Fisk D, Vegso SJ, Van Noppen BL, Price LH. Family accommodation of obsessive-compulsive symptoms: instrument development and assessment of family behavior. J Nerv Ment Dis. 1999 Oct;187(10):636-42. doi: 10.1097/00005053-199910000-00008.
PubMed 10535658Cecconi JP, Lopes AC, Duran FL, Santos LC, Hoexter MQ, Gentil AF, Canteras MM, Castro CC, Noren G, Greenberg BD, Rauch SL, Busatto GF, Miguel EC. Gamma ventral capsulotomy for treatment of resistant obsessive-compulsive disorder: a structural MRI pilot prospective study. Neurosci Lett. 2008 Dec 12;447(2-3):138-42. doi: 10.1016/j.neulet.2008.09.061. Epub 2008 Sep 27.
PubMed 18835422Fodstad H, Strandman E, Karlsson B, West KA. Treatment of chronic obsessive compulsive states with stereotactic anterior capsulotomy or cingulotomy. Acta Neurochir (Wien). 1982;62(1-2):1-23. doi: 10.1007/BF01402207.
PubMed 7048859Frighetto L, De Salles A, Wallace R, Ford J, Selch M, Cabatan-Awang C, Solberg T. Linear accelerator thalamotomy. Surg Neurol. 2004 Aug;62(2):106-13; discussion 113-4. doi: 10.1016/j.surneu.2003.08.033.
PubMed 15261496Frighetto L, Bizzi J, Annes RD, Silva Rdos S, Oppitz P. Stereotactic radiosurgery for movement disorders. Surg Neurol Int. 2012;3(Suppl 1):S10-6. doi: 10.4103/2152-7806.91605. Epub 2012 Jan 14.
PubMed 22826805Goodman WK, Price LH, Rasmussen SA, Mazure C, Delgado P, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. II. Validity. Arch Gen Psychiatry. 1989 Nov;46(11):1012-6. doi: 10.1001/archpsyc.1989.01810110054008.
PubMed 2510699Lopes AC, Greenberg BD, Canteras MM, Batistuzzo MC, Hoexter MQ, Gentil AF, Pereira CA, Joaquim MA, de Mathis ME, D'Alcante CC, Taub A, de Castro DG, Tokeshi L, Sampaio LA, Leite CC, Shavitt RG, Diniz JB, Busatto G, Noren G, Rasmussen SA, Miguel EC. Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):1066-76. doi: 10.1001/jamapsychiatry.2014.1193.
PubMed 25054836Guy W, Wilson WH, Brooking B, Manov G, Fjetland O. Reliability and validity of SAFTEE: preliminar analyses. Psychopharmacol Bull. 1986;22(2):397-401. No abstract available.
PubMed 3774933
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evaluation of Efficacy and Adverse Events of Single Lesions in Bilateral Ventral-capsular and Ventral Capsulotomy-striatal by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02500888
- Acronym / sponsor ID
- 14-0341
- Conditions
- OCD, Quality of Life
- Keywords
- OCD, Neurosurgery, Radiosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Jul 2015 (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 aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.
Detailed description
About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: RadiosurgeryRadiosurgery by linear accelerator. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- OCD diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a major disease entity. If comorbidity with other psychiatric or personality disorders, OCD symptoms dominate the clinical picture and precede other disorders.
- Duration of OCD symptoms of at least five years.
- Scores range of the obsessive-compulsive symptoms "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) greater than 26 (or greater than 13, if obsessions or compulsions alone).
- Fill up the criteria for refractory to prior treatments.
- Be accepted by the method of "best estimate" for defining the patient is refractory, which consisted of confirmation by at least two specialists obsessive-compulsive disorder that the patient fulfills the criteria for effective refractory to previous treatments.
Key exclusion criteria (8 listed)
- History of head trauma or post-traumatic amnesia.
- Background of systemic or neurological diseases with brain impairment, severe and active.
- History of current use of substances capable of inducing psychopathological manifestations, or signs of cumulative effects of alcohol or drugs in the central nervous system (such as cortical atrophy), confirmed by neuroimaging.
- pregnancy or lactation.
- Refusal to submit to the radiosurgical procedure.
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 |
|---|---|---|
| RadiosurgeryOnly one radiation session of about 180 Gy in bilateral internal capsule. | Radiation | Treatment |
Primary outcome
Change in OCD symptoms
Time frame: Every 3 months until 12 months
Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale
11 secondary outcomes
Change in quality of life.
Time frame: Every 3 months until 12 months
Change in brain-derived neurotrophic factor (BDNF) blood dosing
Time frame: 12 months
Change in psychological tests
Time frame: 12 months
Side effects and complications
Time frame: Every 3 months until 12 months
Change in familial accommodation
Time frame: Every 3 months until 12 months
Change in anxiety symptoms.
Time frame: Every 3 months until 12 months
Change in depressive symptoms.
Time frame: Every 3 months until 12 months
Change in near-infrared spectroscopy (NIRS) brain blood flow
Time frame: 12 months
Change in OCD symptoms by CPRS
Time frame: Every 3 months
Change in OCD symptoms by NIMH.
Time frame: Every 3 months
Change in Global Functioning
Time frame: Every 3 months until 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 277059Asberg M, Montgomery SA, Perris C, Schalling D, Sedvall G. A comprehensive psychopathological rating scale. Acta Psychiatr Scand Suppl. 1978;(271):5-27. doi: 10.1111/j.1600-0447.1978.tb02357.x. No abstract available.
- Background: PubMed 5337782Ballantine HT Jr, Cassidy WL, Flanagan NB, Marino R Jr. Stereotaxic anterior cingulotomy for neuropsychiatric illness and intractable pain. J Neurosurg. 1967 May;26(5):488-95. doi: 10.3171/jns.1967.26.5.0488. No abstract available.
- Background: PubMed 19274575Batistuzzo MC, Taub A, Nakano E, D'Alcante CC, de Mathis ME, Hoexter MQ, Miguel EC, Lopes AC. Performance of patients with refractory obsessive-compulsive disorder in the Frontal Systems Behavior Scale. Neurocase. 2009;15(2):157-62. doi: 10.1080/13554790802709047. Epub 2009 Mar 9.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- 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 7575207Brandt RA, Salvajoli JV, Oliveira VC, Carmignani M, da Cruz JC, Leal HD, Ferraz L. [Linear accelerator radiosurgery]. Arq Neuropsiquiatr. 1995 Mar;53(1):38-45. doi: 10.1590/s0004-282x1995000100007. Portuguese.
- Background: PubMed 9525801Calvocoressi L, Libman D, Vegso SJ, McDougle CJ, Price LH. Global functioning of inpatients with obsessive-compulsive disorder, schizophrenia, and major depression. Psychiatr Serv. 1998 Mar;49(3):379-81. doi: 10.1176/ps.49.3.379.
- Background: PubMed 10535658Calvocoressi L, Mazure CM, Kasl SV, Skolnick J, Fisk D, Vegso SJ, Van Noppen BL, Price LH. Family accommodation of obsessive-compulsive symptoms: instrument development and assessment of family behavior. J Nerv Ment Dis. 1999 Oct;187(10):636-42. doi: 10.1097/00005053-199910000-00008.
- Background: PubMed 18835422Cecconi JP, Lopes AC, Duran FL, Santos LC, Hoexter MQ, Gentil AF, Canteras MM, Castro CC, Noren G, Greenberg BD, Rauch SL, Busatto GF, Miguel EC. Gamma ventral capsulotomy for treatment of resistant obsessive-compulsive disorder: a structural MRI pilot prospective study. Neurosci Lett. 2008 Dec 12;447(2-3):138-42. doi: 10.1016/j.neulet.2008.09.061. Epub 2008 Sep 27.
- Background: PubMed 7048859Fodstad H, Strandman E, Karlsson B, West KA. Treatment of chronic obsessive compulsive states with stereotactic anterior capsulotomy or cingulotomy. Acta Neurochir (Wien). 1982;62(1-2):1-23. doi: 10.1007/BF01402207.
- Background: PubMed 15261496Frighetto L, De Salles A, Wallace R, Ford J, Selch M, Cabatan-Awang C, Solberg T. Linear accelerator thalamotomy. Surg Neurol. 2004 Aug;62(2):106-13; discussion 113-4. doi: 10.1016/j.surneu.2003.08.033.
- Background: PubMed 22826805Frighetto L, Bizzi J, Annes RD, Silva Rdos S, Oppitz P. Stereotactic radiosurgery for movement disorders. Surg Neurol Int. 2012;3(Suppl 1):S10-6. doi: 10.4103/2152-7806.91605. Epub 2012 Jan 14.
- Individual participant dataSharing planned: No
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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.
Paulo Abreu, M.D.; Ph.D. principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgery in people with OCD and Quality of Life, run by Hospital de Clinicas de Porto Alegre 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 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Abreu, M.D.; Ph.D. (555133598294, paulo.abreu@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OCD symptoms (time frame: Every 3 months until 12 months). 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 NCT02500888, which also lists 37 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 12 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.