Trials / Completed
CompletedNCT04476446
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Janssen-Cilag, S.A. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression (TRD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esketamine | Participants will receive esketamine at doses of either 56 mg or 84 mg intranasally once or twice a week based on the investigator's clinical judgment. |
Timeline
- Start date
- 2020-09-08
- Primary completion
- 2023-06-16
- Completion
- 2023-06-16
- First posted
- 2020-07-20
- Last updated
- 2023-09-14
Locations
8 sites across 1 country: Mexico
Source: ClinicalTrials.gov record NCT04476446. Inclusion in this directory is not an endorsement.