Trials / Completed
CompletedNCT03756129
Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
A Multi-center, Randomized, subject-and Investigator Blinded, Placebo-controlled, Active Comparator, Parallel-group Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Patients With Treatment-resistant Depression
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a weekly or bi-weekly basis. The efficacy was measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration was 6 weeks of treatment plus 1 month of follow up period.
Detailed description
This was a non-confirmatory, multi-center, 6-treatment arm in European (Spain) and 5-treatment arm in the US (no ketamine arm), randomized, subject and investigator blinded, parallel-group, placebo-controlled study in patients with treatment-resistant depression. The total duration for each subject in the study was maximum 14 weeks: a screening period of maximum 4 weeks, a 36-day treatment period and a 5-week follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MIJ821 | Different dosages and different regimen for MIJ821 |
| DRUG | Placebo | Infusion |
| DRUG | Ketamine | Infusion |
Timeline
- Start date
- 2019-02-08
- Primary completion
- 2020-03-23
- Completion
- 2020-03-23
- First posted
- 2018-11-28
- Last updated
- 2021-10-08
- Results posted
- 2021-05-19
Locations
12 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03756129. Inclusion in this directory is not an endorsement.