A Long-Term Safety Study of ALKS 5461
A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
Sponsor: Alkermes, Inc.
Listed as NCT02141399, this PHASE3 trial focuses on Major Depressive Disorder and remains completed. Sponsored by Alkermes, Inc., it has been updated 9 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
9 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2019 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 4 earlier versions
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Jun 2018 — Jan 2019 [monthly]
Completed PHASE3
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Jan 2018 — Jun 2018 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Feb 2017 — Jan 2018 [monthly]
Active Not Recruiting PHASE3
Status: Enrolling By Invitation → Active Not Recruiting
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Jan 2017 — Feb 2017 [monthly]
Enrolling By Invitation PHASE3
First recorded
May 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Alkermes, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .