NCT05454410CompletedPhase 2
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Jun 2022
- Start date
- 13 Mar 2023
- Primary completion date
- 28 Nov 2023
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Depression
- NCT number
- NCT05454410
- EudraCT number
- 2021-005992-38
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 13 Mar 2023 to the primary completion date, 28 Nov 2023
- 14 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants with current borderline personality disorder or antisocial personality disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.