Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Depressive Disorder, Treatment-Resistant
In brief
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.
Key facts
- Study ID
- NCT03756129
- Run by
- Novartis Pharmaceuticals
- People needed
- 70
- Starts
- 2019-02-08
- Expected to finish
- 2020-03-23
- Last updated by the study team
- 2021-10-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Garden Grove, California, United States
- Novartis Investigative Site — Oakland, California, United States
- Novartis Investigative Site — Bradenton, Florida, United States
- Novartis Investigative Site — Atlanta, Georgia, United States
- Novartis Investigative Site — Skokie, Illinois, United States
- Novartis Investigative Site — Rockville, Maryland, United States
- Novartis Investigative Site — Berlin, New Jersey, United States
- Novartis Investigative Site — Palma de Mallorca, Balearic Islands, Spain
- Novartis Investigative Site — Vitoria-Gasteiz, Basque Country, Spain
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Barcelona, Spain
Full record on ClinicalTrials.gov
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