Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05454410
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2022-06-16
Brief Title:
Study of Efficacy Safety Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression TRD
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005992-38 | EUDRACT_NUMBER | None | None |