A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Public ClinicalTrials.gov record NCT02158533. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Study identification
- NCT ID
- NCT02158533
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alkermes, Inc.
- Industry
- Enrollment
- 385 participants
Conditions and interventions
Conditions
Interventions
- High Dose ALKS 5461 Drug
- Low Dose ALKS 5461 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2014
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Aug 13, 2019
2014 – 2015
United States locations
- U.S. sites
- 42
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alkermes Investigational Site | Birmingham | Alabama | 35226 | — |
| Alkermes Investigational Site | Tucson | Arizona | 85712 | — |
| Alkermes Investigational Site | Carson | California | 90746 | — |
| Alkermes Investigational Site | National City | California | 91950 | — |
| Alkermes Investigational Site | Orange | California | 92868 | — |
| Alkermes Investigational Site | Sherman Oaks | California | 91403 | — |
| Alkermes Investigational Site | Torrance | California | 90502 | — |
| Alkermes Investigational Site | Upland | California | 91786 | — |
| Alkermes Investigational Site | Hartford | Connecticut | 06106 | — |
| Alkermes Investigational Site | Norwich | Connecticut | 06360 | — |
| Alkermes Investigational Site | Coral Springs | Florida | 33067 | — |
| Alkermes Investigational Site | Gainesville | Florida | 32607 | — |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | — |
| Alkermes Investigational Site | Orlando | Florida | 32801 | — |
| Alkermes, Investigational Site | Alpharetta | Georgia | 30005 | — |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | — |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | — |
| Alkermes Investigational Site | Joliet | Illinois | 60435 | — |
| Alkermes Investigational Site | Skokie | Illinois | 60076 | — |
| Alkermes Investigational Site | Newburgh | Indiana | 47630 | — |
| Alkermes Investigational Site | Valparaiso | Indiana | 46383 | — |
| Alkermes Investigational Site | Owensboro | Kentucky | 42301 | — |
| Alkermes Investigational Site | Baltimore | Maryland | 21208 | — |
| Alkermes Investigational Site | Baltimore | Maryland | 21285 | — |
| Alkermes Investigational Site | Berlin | New Jersey | 08009 | — |
| Alkermes Investigational Site | Brooklyn | New York | 11241 | — |
| Alkermes Investigational Site | Mount Kisco | New York | 10549 | — |
| Alkermes Investigational Site | New York | New York | 10128 | — |
| Alkermes Investigational Site | Staten Island | New York | 10305 | — |
| Alkermes Investigational Site | Canton | Ohio | 44718 | — |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | — |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | — |
| Alkermes Investigational Site | Media | Pennsylvania | 19063 | — |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| Alkermes Investigational Site | Lincoln | Rhode Island | 02865 | — |
| Alkermes Investigational Site | Austin | Texas | 78731 | — |
| Alkermes Investigational Site | Houston | Texas | 77081 | — |
| Alkermes Investigational Site | San Antonio | Texas | 78229 | — |
| Alkermes Investigational Site | Woodstock | Vermont | 05091 | — |
| Alkermes Investigational Site | Middleton | Wisconsin | 53562 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02158533, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2019 · Synced Jul 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02158533 live on ClinicalTrials.gov.