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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005992-38 | EudraCT Number |
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The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)
The trial included a screening period of up to 28 days. On Day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of MIJ821) or placebo and received study treatment administered as a single subcutaneous injection. Participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits occurred 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments included the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments included laboratory tests, ECGs, vital signs and physical examinations. In addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the End-of-study (EOS) visit. EOS visit was completed on site on Day 29. Including screening, participants were in the study for up to 8 weeks (57 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIJ821 1 mg | Experimental | Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. |
|
| MIJ821 4 mg | Experimental | Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1. |
|
| MIJ821 10 mg | Experimental | Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1. |
|
| Placebo | Placebo Comparator | Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIJ821 Subcutaneous Injection 1 mg | Drug | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection | The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel. | Baseline and 24 hours after SC injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs) | A TEAE was defined as an adverse event starting or worsening after the administration of study medication and up to the end of study visit. The following events were considered AESIs:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 25Uni of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Research Centers of America LLC |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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All inclusion and exclusion criteria were checked during screening and on Day 1, prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | MIJ821 10 mg | Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. |
| FG001 | MIJ821 4 mg | Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2022 | Nov 27, 2024 |
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| MIJ821 Subcutaneous Injection 4 mg | Drug | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
|
| MIJ821 Subcutaneous Injection 10 mg | Drug | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
|
| Placebo Subcutaneous Injection | Drug | 0.9% sodium chloride solution administered as a single SC injection on Day 1. |
|
| From Day 1 after SC injection to end of study, up to 29 Days |
| Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast) | Blood samples were collected at the indicated time points for PK analysis. AUClast was defined as the area under the curve from time zero to the last measurable concentration sampling time (tlast). | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax) | Blood samples were collected at the indicated time points for PK analysis. Cmax was defined as the maximum (peak) observed plasma drug concentration after single dose administration. | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax) | Blood samples were collected at the indicated time points for PK analysis. Tmax was defined as the time to reach maximum (peak) plasma drug concentration after single dose administration (time). | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits | The MADRS (SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel. | Baseline, Days 8, 15, 22 and 29 |
| Dose-response (DR) Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score at 24 Hours After Single SC Injection | The multiple comparison procedure - modelling (MCP-Mod) approach was an integrated approach used to investigate DR relationships, while confirming efficacy of the test product based on hypothesis testing. A set of candidate models was tested using Multiple Comparison Procedures (MCP) that preserve the family-wise error rate (FWER) to determine the model best representing the underlying DR. Efficacy via DR was established when at least one of the model tests was significant. | Baseline up to 24 Hours |
| Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | Baseline, Day 2, 15, 22 and 29 |
| Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (Cmax) | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | Baseline, Day 2, 15, 22 and 29 |
| Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (AUClast) | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | Baseline, Day 2, 15, 22 and 29 |
| Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | Baseline, Day 2, 15, 22 and 29 |
| Oakland Park |
| Florida |
| 33334 |
| United States |
| Interventional Psychiatry Tampa Bay | Tampa | Florida | 33629 | United States |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Kodaira | Tokyo | 187-8551 | Japan |
| Novartis Investigative Site | Mitaka | Tokyo | 181-8611 | Japan |
| Novartis Investigative Site | Bialystok | 15 276 | Poland |
| Novartis Investigative Site | Gdansk | 80 952 | Poland |
| Novartis Investigative Site | Swiecie North West | 86-100 | Poland |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Sabadell | Barcelona | 08208 | Spain |
| Novartis Investigative Site | Sant Boi de Llobregat | Barcelona | 08830 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| FG002 | MIJ821 1 mg | Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1. |
| FG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Randomized set included all Randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MIJ821 10 mg | Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous injection on Day 1. |
| BG001 | MIJ821 4 mg | Participants received a single dose of 4 mg MIJ821 administered as a subcutaneous injection on Day 1. |
| BG002 | MIJ821 1 mg | Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous injection on Day 1. |
| BG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a subcutaneous injection on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection | The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel. | The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline and 24 hours after SC injection |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs) | A TEAE was defined as an adverse event starting or worsening after the administration of study medication and up to the end of study visit. The following events were considered AESIs:
| The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received. | Posted | Count of Participants | Participants | From Day 1 after SC injection to end of study, up to 29 Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast) | Blood samples were collected at the indicated time points for PK analysis. AUClast was defined as the area under the curve from time zero to the last measurable concentration sampling time (tlast). | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax) | Blood samples were collected at the indicated time points for PK analysis. Cmax was defined as the maximum (peak) observed plasma drug concentration after single dose administration. | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax) | Blood samples were collected at the indicated time points for PK analysis. Tmax was defined as the time to reach maximum (peak) plasma drug concentration after single dose administration (time). | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Median | Full Range | hour (h) | Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits | The MADRS (SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel. | The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline, Days 8, 15, 22 and 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dose-response (DR) Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score at 24 Hours After Single SC Injection | The multiple comparison procedure - modelling (MCP-Mod) approach was an integrated approach used to investigate DR relationships, while confirming efficacy of the test product based on hypothesis testing. A set of candidate models was tested using Multiple Comparison Procedures (MCP) that preserve the family-wise error rate (FWER) to determine the model best representing the underlying DR. Efficacy via DR was established when at least one of the model tests was significant. | The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline up to 24 Hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Number | Scores on a scale | Baseline, Day 2, 15, 22 and 29 |
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| Secondary | Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (Cmax) | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Number | ng/mL | Baseline, Day 2, 15, 22 and 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (AUClast) | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Number | h*ng/mL | Baseline, Day 2, 15, 22 and 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter | The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter. | The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data. | Posted | Number | Hill coefficient | Baseline, Day 2, 15, 22 and 29 |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIJ821 10 mg | Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG001 | MIJ821 4mg | Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1. | 0 | 14 | 0 | 14 | 6 | 14 |
| EG002 | MIJ821 1mg | Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a subcutaneous injection on Day 1. | 0 | 17 | 0 | 17 | 7 | 17 |
| EG004 | All MIJ821 | All MIJ821 Dosages | 0 | 43 | 0 | 43 | 20 | 43 |
| EG005 | All Participants | All Participants included in the Safety Analysis Set | 0 | 60 | 0 | 60 | 27 | 60 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Derealisation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dissociation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2024 | Nov 27, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Female |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian / Japanese |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Mean Difference (Net) |
| -2.5 |
| 2-Sided |
| 90 |
| -7.0 |
| 2.1 |
Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity. |
| Superiority |
| ANCOVA | Mean Difference (Net) | 0.6 | 2-Sided | 90 | -4.0 | 5.1 | Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity. | Superiority |
| OG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1. |
| OG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1. |
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| OG003 | Placebo | Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1. |
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