A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT02085135. 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, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Study identification
- NCT ID
- NCT02085135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 66 participants
Conditions and interventions
Conditions
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
- Jan 31, 2014
- Primary completion
- Aug 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Aug 13, 2019
2014
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alkermes Investigational Site | Jacksonville | Florida | 32256 | — |
| Alkermes Investigational Site | Orlando | Florida | 32806 | — |
| Alkermes Investigational Site | Atlanta | Georgia | 30308 | — |
| Alkermes Investigational Site | Saint Charles | Missouri | 63304 | — |
| Alkermes Investigational Site | Staten Island | New York | 10305 | — |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | — |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | — |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02085135, 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 Sep 3, 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 NCT02085135 live on ClinicalTrials.gov.