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Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

Primary Purpose

Treatment-Resistant Depression

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MIJ821 Subcutaneous Injection - low dose
MIJ821 Subcutaneous Injection - medium dose
MIJ821 Subcutaneous Injection - high dose
Placebo Subcutaneous Injection
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-Resistant Depression focused on measuring Treatment-Resistant Depression, Major Depressive Episode, Major Depressive Disorder, MIJ821, Anti-depressive Agent, Subcutaneous, Placebo, Adult

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent must be 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MIJ821 - low dose

MIJ821 - medium dose

MIJ821 - high dose

Placebo

Arm Description

Single subcutaneous administration of low dose of MIJ821 on Day 1

Single subcutaneous administration of medium dose of MIJ821 on Day 1

Single subcutaneous administration of high dose of MIJ821 on Day 1

Single subcutaneous administration of 0.9% sodium chloride on Day 1

Outcomes

Primary Outcome Measures

Change from baseline in MADRS total score 24 hours after injection
The Montgomery Asberg 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 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 will be collected electronically by qualified personnel.

Secondary Outcome Measures

Number of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs)
Number of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs) will be collected at all study visits. AESIs include dissociation, sedation, cardiovascular and respiratory effect, suicidality, memory gaps/amnesia, cystitis or lower urinary tract adverse events
Pharmacokinetics (PK) of MIJ821 in plasma for AUClast
AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Pharmacokinetics (PK) of MIJ821 in plasma for Cmax
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Pharmacokinetics (PK) of MIJ821 in plasma for Tmax
Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
MADRS total scores
The Montgomery Asberg 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 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 will be collected electronically by qualified personnel.
Dose-response relationship of MIJ821
Correlation between MIJ821 dose and change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score at 24 hours. The MADRS 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 60. Higher scores represent a more severe condition.
Exposure-response relationship of MIJ821
Correlation between MIJ821 exposure and the Montgomery Asberg Depression Rating Scale (MADRS) total score at 24 hours. MADRS 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 60. Higher scores represent a more severe condition.

Full Information

First Posted
June 16, 2022
Last Updated
July 11, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05454410
Brief Title
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
January 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is 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
Approximately 56 participants will be randomized in a total of 20-25 centers worldwide. The trial consists of screening period of up to 28 days. On Day 1, eligible participants will be randomized to one of the treatment arms (low, medium or high dose of MIJ821) or placebo and receive study treatment administered as a single subcutaneous injection. Participant will remain 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 will occur 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments will include the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments include laboratory tests, ECGs, vital signs and physical examinations. In addition phone calls will be conducted 3 days after each on-site clinic visit with the exception of End-of-study (EOS) visit. EOS visit will be completed on site on Day 29. The total duration of the study is approximately 8 weeks (56 days), including screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-Resistant Depression
Keywords
Treatment-Resistant Depression, Major Depressive Episode, Major Depressive Disorder, MIJ821, Anti-depressive Agent, Subcutaneous, Placebo, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIJ821 - low dose
Arm Type
Experimental
Arm Description
Single subcutaneous administration of low dose of MIJ821 on Day 1
Arm Title
MIJ821 - medium dose
Arm Type
Experimental
Arm Description
Single subcutaneous administration of medium dose of MIJ821 on Day 1
Arm Title
MIJ821 - high dose
Arm Type
Experimental
Arm Description
Single subcutaneous administration of high dose of MIJ821 on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single subcutaneous administration of 0.9% sodium chloride on Day 1
Intervention Type
Drug
Intervention Name(s)
MIJ821 Subcutaneous Injection - low dose
Intervention Description
MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1
Intervention Type
Drug
Intervention Name(s)
MIJ821 Subcutaneous Injection - medium dose
Intervention Description
MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1
Intervention Type
Drug
Intervention Name(s)
MIJ821 Subcutaneous Injection - high dose
Intervention Description
MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1
Intervention Type
Drug
Intervention Name(s)
Placebo Subcutaneous Injection
Intervention Description
0.9% sodium chloride solution to be administered as a single subcutaneous injection on Day 1
Primary Outcome Measure Information:
Title
Change from baseline in MADRS total score 24 hours after injection
Description
The Montgomery Asberg 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 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 will be collected electronically by qualified personnel.
Time Frame
Baseline and 24 hours after s.c. injection
Secondary Outcome Measure Information:
Title
Number of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs)
Description
Number of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs) will be collected at all study visits. AESIs include dissociation, sedation, cardiovascular and respiratory effect, suicidality, memory gaps/amnesia, cystitis or lower urinary tract adverse events
Time Frame
Baseline up to 29 days
Title
Pharmacokinetics (PK) of MIJ821 in plasma for AUClast
Description
AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
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
Title
Pharmacokinetics (PK) of MIJ821 in plasma for Cmax
Description
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
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
Title
Pharmacokinetics (PK) of MIJ821 in plasma for Tmax
Description
Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
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
Title
MADRS total scores
Description
The Montgomery Asberg 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 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 will be collected electronically by qualified personnel.
Time Frame
Baseline, Day 8, Day 15, Day 22 and 29
Title
Dose-response relationship of MIJ821
Description
Correlation between MIJ821 dose and change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score at 24 hours. The MADRS 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 60. Higher scores represent a more severe condition.
Time Frame
Baseline up to 24 hours
Title
Exposure-response relationship of MIJ821
Description
Correlation between MIJ821 exposure and the Montgomery Asberg Depression Rating Scale (MADRS) total score at 24 hours. MADRS 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 60. Higher scores represent a more severe condition.
Time Frame
Baseline up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent must be 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kashihara city
State/Province
Nara
ZIP/Postal Code
634 8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mitaka-city
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pruszkow
State/Province
Mazowieckie
ZIP/Postal Code
05-802
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15 276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80 952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Swiecie n/W
ZIP/Postal Code
86-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sant Boi de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 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

Learn more about this trial

Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

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