Treatment-Resistant DepressionPhase 2NCT05454410
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
A Phase 2 study testing MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg and MIJ821 Subcutaneous Injection 10 mg in people with Treatment-Resistant Depression, run by Novartis Pharmaceuticals at 16 sites in 4 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-Resistant Depression
- What is being tested?
- MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg and MIJ821 Subcutaneous Injection 10 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 13 Mar 2023to 28 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained prior to participation in the study
- Male and female participants, 18 to 65 years of age (inclusive) at screening
- DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
- MADRS score ≥ 24
- Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants
Who cannot join
- Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
- Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
- Participants with current borderline personality disorder or antisocial personality disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Spain7 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Sant Boi de Llobregat, Barcelona, 08830
Novartis Investigative Site
Seville, Andalusia, 41013
United States3 sites
25Uni of Alabama at Birmingham
Birmingham, Alabama, 35294
Research Centers of America LLC
Oakland Park, Florida, 33334
Interventional Psychiatry Tampa Bay
Tampa, Florida, 33629
Japan3 sites
Novartis Investigative Site
Kodaira, Tokyo, 187-8551
Novartis Investigative Site
Mitaka, Tokyo, 181-8611
Novartis Investigative Site
Yokohama, Kanagawa, 236-0004
Poland3 sites
Novartis Investigative Site
Bialystok, 15 276
Novartis Investigative Site
Gdansk, 80 952
Novartis Investigative Site
Swiecie North West, 86-100
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression
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)
Read the detailed description
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).
- Conditions
- Treatment-Resistant Depression
- Being tested
- MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg, MIJ821 Subcutaneous Injection 10 mg, Placebo Subcutaneous Injection
- Keywords
- Treatment-Resistant Depression, Major Depressive Episode, Major Depressive Disorder, MIJ821, Anti-depressive Agent, Subcutaneous, Placebo, Adult
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIJ821 Subcutaneous Injection 1 mgDrug
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 4 mgDrug
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 mgDrug
MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.
Placebo Subcutaneous InjectionDrug
0.9% sodium chloride solution administered as a single SC injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| MIJ821 1 mg | Experimental | Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. Receives: Drug: MIJ821 Subcutaneous Injection 1 mg |
| MIJ821 4 mg | Experimental | Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1. Receives: Drug: MIJ821 Subcutaneous Injection 4 mg |
| MIJ821 10 mg | Experimental | Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1. Receives: Drug: MIJ821 Subcutaneous Injection 10 mg |
| Placebo | Placebo comparator | Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1. Receives: Drug: Placebo Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 hours after SC injection
Secondary outcomes (10)
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:
- Dissociation
- Sedation
- Cardiovascular effects (Blood Pressure changes and QT interval prolongation on electrocardiogram [ECG])
- Respiratory effects (difficulty in breathing, changes in oxygen saturation)
- Suicidality (suicidal ideation or behavior)
- Memory gaps/amnesia
- Cystitis or lower urinary tract adverse events
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 2, 15, 22 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start13 Mar 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment-Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454410
- Sponsor's protocol ID
- CMIJ821B12201
- Other IDs
- 2021-005992-38
- Status last verified
- Apr 2025
- First submitted
- 16 Jun 2022
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT05454410
- Acronym / sponsor ID
- CMIJ821B12201
- Conditions
- Treatment-Resistant Depression
- Keywords
- Treatment-Resistant Depression, Major Depressive Episode, Major Depressive Disorder, MIJ821, Anti-depressive Agent, Subcutaneous, Placebo, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MIJ821 1 mg | Experimental | Drug: MIJ821 Subcutaneous Injection 1 mgParticipants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. |
| MIJ821 4 mg | Experimental | Drug: MIJ821 Subcutaneous Injection 4 mgParticipants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1. |
| MIJ821 10 mg | Experimental | Drug: MIJ821 Subcutaneous Injection 10 mgParticipants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1. |
| Placebo | Placebo comparator | Drug: Placebo Subcutaneous InjectionParticipants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent obtained prior to participation in the study
- Male and female participants, 18 to 65 years of age (inclusive) at screening
- DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
- MADRS score ≥ 24
- Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants
Key exclusion criteria (4 listed)
- Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
- Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
- Participants with current borderline personality disorder or antisocial personality disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability
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 |
|---|---|---|
| MIJ821 Subcutaneous Injection 1 mgMIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. | Drug | MIJ821 1 mg |
| MIJ821 Subcutaneous Injection 4 mgMIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. | Drug | MIJ821 4 mg |
| MIJ821 Subcutaneous Injection 10 mgMIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. | Drug | MIJ821 10 mg |
| Placebo Subcutaneous Injection0.9% sodium chloride solution administered as a single SC injection on Day 1. | Drug | Placebo |
Primary outcome
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection
Time frame: Baseline and 24 hours after SC 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.
10 secondary outcomes
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline, Day 2, 15, 22 and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg and MIJ821 Subcutaneous Injection 10 mg in people with Treatment-Resistant Depression, run by Novartis Pharmaceuticals at 16 sites in 4 countries.
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 4 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United States, Japan, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection (time frame: Baseline and 24 hours after SC injection). 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 13 Apr 2025.