Major Depressive DisorderPhase 3NCT06698666
Efficacy of Statins Among Major Depressive Disorder
A Phase 3 study testing Rosuvastatin 10 mg tablet. and Sertraline Pill in people with Major Depressive Disorder and MDD, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are: Does Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, MDD
- What is being tested?
- Rosuvastatin 10 mg tablet. and Sertraline Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 20 and 45 years;
- diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);
- The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;
- the ability to give informed consent and to comply with standard procedures;
- Males and females; and
- Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated.
Who cannot join
- lifetime or current SCID-I/P diagnosis of a psychotic disorder;
- lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;
- acute or unstable systemic medical disorder;
- inability to comply with the requirements of informed consent or the study protocol;
- history of intolerance or allergy to study medications;
- Current pregnancy or breast feeding;
- Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and
- Females on Contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
El demerdash hospital
Cairo, Al Abbasia, +02
Silvana Nader, 01226058776, Slvana_nader@med.asu.edu.eg
About this study
Official title: The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.
The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are:
Does Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( MDD )? What medical problems do participants have when taking drug ABC?
Participants will:
Take Rosuvastatin 10 mg every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Report any side effects for Rosuvastatin 10 mg and reassess the severity of depression using The Montgomery Asberg Depression Rating Scale (MADRS)
Read the detailed description
- Type of Study: Randomised Controlled Trial (RCT)
- Study Setting: Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals.
- Study Period: starting from September 2022 till completion of sample size
- Study Population
Any adult patient aged 20 -45 years old attending the psychiatric clinic at the Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals with mild or moderate depression.
Diagnostic criteria for minor depression according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
We diagnose minor depressive episodes according to all of the following criteria (A through F).
- Two to four of the following symptoms have been present during the same two-week period:
- Dysphoria - Depressed mood most of the day, nearly every day
- Anhedonia - Markedly diminished interest or pleasure most of the day, nearly every day
- Significant appetite or weight change
- Insomnia or hypersomnia nearly every day
- Psychomotor agitation or retardation (observable by others)
- Anergia - Fatigue nearly every day
- Thoughts of worthlessness or inappropriate guilt nearly every day
- Impaired concentration or memory nearly every day
- Recurrent thoughts of death or suicide, or suicide attempt
- At least one of the symptoms includes dysphoria or anhedonia C. The symptoms cause clinically significant distress of psychosocial impairment D. The symptoms are not due to the physiologic effects of a substance, medication, or general medical condition E. Persistent depressive disorder (dysthymia) and cyclothymic disorder are not present F. The mood disturbance does not occur exclusively during a psychotic disorder
- Sampling Method: Convenience sample
- Sample Size
Using G power software for sample size calculation, setting power at 80% and alpha error at 0.05, it is estimated that sample size of 65 patients per group will be needed to detect a statistical difference between two groups regarding MADRS score after 12 weeks assuming medium effect size, difference between two groups (Cohen's coefficient = 0.5.
Assuming 10% dropout rate, sample size of 72 participants per group will be needed.
Ethical Considerations
- Approval from the research ethical committee of Faulty of Medicine Ain Shams University will be taken.
- An informed consent will be used to inform the participants about all the steps of the study and the risks and benefits of the study.
- Anonymous questionnaires will be used to assure confidentiality of the data. Regarding the Confidentiality of data, the Principle investigator and Co -investigator will be the only persons having access to the patient's data.
Study Tools
- First, a baseline line assessment will be done by obtaining the socio-demographic data (including age, gender, level of education, occupation, marital status, residence and family history of any psychiatric illness ) for the whole participants
- Second, diagnosis of major depressive disorder will be confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P)
The Structured Clinical Interview for DSM-4-Clinician Edition is a screening procedure used to diagnose DSM-4 Axis I disorders (major psychiatric disorders). It comprises seven diagnostic modules based on various diagnostic groups: mood disorders, depression, drug abuse, anxiety, somatoform disorders, eating disorders, and adjustment disorders. El-Missiry translated the SCID-I-CV into Arabic in 2004, and its use was confirmed in various studies performed in Egyptian study centers.
- Third, severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34.
- The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.
- Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
- The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Usual cutoff points are:
- 0 to 6 - normal /symptom absent
- 7 to 19 - mild depression
- 20 to 34 - moderate depression
- >34 - severe depression.
- Time: Interviews take 20 to 60 minutes to complete.
- Subscales: The MADRS has 10 subtests (each item is therefore considered a subtest): 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts
- Equipment: Only the questionnaire and a pencil are required to complete the MADRS.
- Training: No formal training is required to complete the MADRS.
- Fourth, serum cholesterol level will be drawn and sent to the central laboratories of El-Demerdash hospital at baseline and at week 12.
- Conditions
- Major Depressive Disorder, MDD
- Being tested
- Rosuvastatin 10 mg tablet., Sertraline Pill
- Keywords
- Rosuvastatin, Major depressive disorder, MADRS scale
- 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.
Rosuvastatin 10 mg tablet.Drug
The dose of rosuvastatin was derived from literature describing the doses at which the agents' targeted actions are effective and safe. The 10- mg rosuvastatin dose reflects the lowest prescribed therapeutic dose A serum cholesterol level will be drawn from the whole participants and sent to the central laboratories of El-Demerdash hospital at baseline and at week 12.
At each visit, participants will be requested to return all unused investigational products. Adherence to medication will be assessed by a pill count.
Sertraline PillDrug
Both control and intervention group will receive the sertraline as a standard therapy
| Study group | Role | What they receive |
|---|---|---|
| The Control Group | Other | The Control Group will receive the standard treatment of depression including SSRI (Sertraline) only |
| The Interventional group | Experimental | the interventional group will receive the standard treatment of depression including SSRI (Sertraline) in addition to the10 mg/day rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depression among Participants with MDD as Assessed by MADRS scale
Severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34.
- The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.
- Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
- The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
- Time:
Interviews take 20 to 60 minutes to complete.
Measured: 3 months (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Oct 2022
- Primary completion4 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- \- Study Interventions The study is a 12-week, parallel group, randomised controlled trial (RCT) in participants with mild to moderate MDD. A baseline line assessment will be done by obtaining the socio-demographic data for the whole participants and The participants will be allocated into either groups First Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI)(Sertraline). Second Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI) (Sertraline) and rosuvastatin 10 mg/day. Assessments will be scheduled at baseline and weeks 4, 8, and 12. Randomisation and Blinding: Participants will be allocated into either 2 groups: control group (SSRI only) or interventional group (SSRI plus statins) randomly by giving them sealed envelopes containing code for control or interventional group Interventions: The participant will be randomly assigned to the interventional, or control group on a 1:1 basis.
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Nader, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698666
- Sponsor's protocol ID
- 187/2022
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.
- ClinicalTrials.gov ID
- NCT06698666
- Acronym / sponsor ID
- 187/2022
- Conditions
- Major Depressive Disorder, MDD
- Keywords
- Rosuvastatin, Major depressive disorder, MADRS scale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- 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 goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are:
Does Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( MDD )? What medical problems do participants have when taking drug ABC?
Participants will:
Take Rosuvastatin 10 mg every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Report any side effects for Rosuvastatin 10 mg and reassess the severity of depression using The Montgomery Asberg Depression Rating Scale (MADRS)
Detailed description
- Type of Study: Randomised Controlled Trial (RCT)
- Study Setting: Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals.
- Study Period: starting from September 2022 till completion of sample size
- Study Population
Any adult patient aged 20 -45 years old attending the psychiatric clinic at the Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals with mild or moderate depression.
Diagnostic criteria for minor depression according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
We diagnose minor depressive episodes according to all of the following criteria (A through F).
- Two to four of the following symptoms have been present during the same two-week period:
- Dysphoria - Depressed mood most of the day, nearly every day
- Anhedonia - Markedly diminished interest or pleasure most of the day, nearly every day
- Significant appetite or weight change
- Insomnia or hypersomnia nearly every day
- Psychomotor agitation or retardation (observable by others)
- Anergia - Fatigue nearly every day
- Thoughts of worthlessness or inappropriate guilt nearly every day
- Impaired concentration or memory nearly every day
- Recurrent thoughts of death or suicide, or suicide attempt
- At least one of the symptoms includes dysphoria or anhedonia C. The symptoms cause clinically significant distress of psychosocial impairment D. The symptoms are not due to the physiologic effects of a substance, medication, or general medical condition E. Persistent depressive disorder (dysthymia) and cyclothymic disorder are not present F. The mood disturbance does not occur exclusively during a psychotic disorder
- Sampling Method: Convenience sample
- Sample Size
Using G power software for sample size calculation, setting power at 80% and alpha error at 0.05, it is estimated that sample size of 65 patients per group will be needed to detect a statistical difference between two groups regarding MADRS score after 12 weeks assuming medium effect size, difference between two groups (Cohen's coefficient = 0.5.
Assuming 10% dropout rate, sample size of 72 participants per group will be needed.
Ethical Considerations
- Approval from the research ethical committee of Faulty of Medicine Ain Shams University will be taken.
- An informed consent will be used to inform the participants about all the steps of the study and the risks and benefits of the study.
- Anonymous questionnaires will be used to assure confidentiality of the data. Regarding the Confidentiality of data, the Principle investigator and Co -investigator will be the only persons having access to the patient's data.
Study Tools
- First, a baseline line assessment will be done by obtaining the socio-demographic data (including age, gender, level of education, occupation, marital status, residence and family history of any psychiatric illness ) for the whole participants
- Second, diagnosis of major depressive disorder will be confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P)
The Structured Clinical Interview for DSM-4-Clinician Edition is a screening procedure used to diagnose DSM-4 Axis I disorders (major psychiatric disorders). It comprises seven diagnostic modules based on various diagnostic groups: mood disorders, depression, drug abuse, anxiety, somatoform disorders, eating disorders, and adjustment disorders. El-Missiry translated the SCID-I-CV into Arabic in 2004, and its use was confirmed in various studies performed in Egyptian study centers.
- Third, severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34.
- The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.
- Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
- The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Usual cutoff points are:
- 0 to 6 - normal /symptom absent
- 7 to 19 - mild depression
- 20 to 34 - moderate depression
- >34 - severe depression.
- Time: Interviews take 20 to 60 minutes to complete.
- Subscales: The MADRS has 10 subtests (each item is therefore considered a subtest): 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts
- Equipment: Only the questionnaire and a pencil are required to complete the MADRS.
- Training: No formal training is required to complete the MADRS.
- Fourth, serum cholesterol level will be drawn and sent to the central laboratories of El-Demerdash hospital at baseline and at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- - Study Interventions The study is a 12-week, parallel group, randomised controlled trial (RCT) in participants with mild to moderate MDD. A baseline line assessment will be done by obtaining the socio-demographic data for the whole participants and The participants will be allocated into either groups First Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI)(Sertraline). Second Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI) (Sertraline) and rosuvastatin 10 mg/day. Assessments will be scheduled at baseline and weeks 4, 8, and 12. Randomisation and Blinding: Participants will be allocated into either 2 groups: control group (SSRI only) or interventional group (SSRI plus statins) randomly by giving them sealed envelopes containing code for control or interventional group Interventions: The participant will be randomly assigned to the interventional, or control group on a 1:1 basis.
| Arm | Type | Receives |
|---|---|---|
| The Control Group | Other | –The Control Group will receive the standard treatment of depression including SSRI (Sertraline) only |
| The Interventional group | Experimental | –the interventional group will receive the standard treatment of depression including SSRI (Sertraline) in addition to the10 mg/day rosuvastatin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged between 20 and 45 years;
- diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);
- The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;
- the ability to give informed consent and to comply with standard procedures;
- Males and females; and
Key exclusion criteria (8 listed)
- lifetime or current SCID-I/P diagnosis of a psychotic disorder;
- lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;
- acute or unstable systemic medical disorder;
- inability to comply with the requirements of informed consent or the study protocol;
- history of intolerance or allergy to study medications;
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 |
|---|---|---|
| Rosuvastatin 10 mg tablet.The dose of rosuvastatin was derived from literature describing the doses at which the agents' targeted actions are effective and safe. The 10- mg rosuvastatin dose reflects the lowest prescribed therapeutic dose A serum cholesterol level will be drawn from the whole participants and sent to the central laboratories of El-Demerdash hospital at baseline and at week 12. At each visit, participants will be requested to return all unused investigational products. Adherence to medication will be assessed by a pill count. | Drug | – |
| Sertraline PillBoth control and intervention group will receive the sertraline as a standard therapy | Drug | – |
Primary outcome
Severity of depression among Participants with MDD as Assessed by MADRS scale
Time frame: 3 months (12 weeks)
Severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34. * The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. * Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. * The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts * Time: Interviews take 20 to 60 minutes to complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin 10 mg tablet. and Sertraline Pill in people with Major Depressive Disorder and MDD, run by Ain Shams University at 1 site in Egypt.
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 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Egypt. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvana Nader (01226058776, Slvana_nader@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depression among Participants with MDD as Assessed by MADRS scale (time frame: 3 months (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.