Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT01381107

ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)

Sponsor: Alkermes, Inc.

Conditions Major Depressive Disorder

Interventions ALKS 5461 Placebo

Updated 7 times since 2017 Last updated: Aug 18, 2011 Started: May 31, 2011 Primary completion: Jul 31, 2011 Completion: Jul 31, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Major Depressive Disorder and is currently completed. Alkermes, Inc. leads this study, which shows 7 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE1_PHASE2
Jan 2021 — Apr 2022 [monthly]

Completed PHASE1_PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1_PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1_PHASE2

First recorded

May 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alkermes, Inc.

Data source: Alkermes, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Atlanta, United States
• St. Petersburg, United States