NCT02085135

Brief Summary

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 27, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

March 7, 2014

Results QC Date

March 1, 2019

Last Update Submit

August 2, 2019

Conditions

Major Depressive Disorder

Keywords

depressionmajor depressive disorderAlkermesALKS 5461samidorphanbuprenorphine

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Adverse Events (AEs)

    8 weeks

Study Arms (2)

Titration Schedule 1

EXPERIMENTAL
Drug: ALKS 5461

Titration Schedule 2

EXPERIMENTAL
Drug: ALKS 5461

Interventions

ALKS 5461DRUG

Sublingual tablet taken once daily

Titration Schedule 1Titration Schedule 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index of 18-40 kg/m2
  • Have a diagnosis of MDD
  • Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
  • Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
  • Have an inadequate response to current antidepressant treatment
  • Agree to use an approved method of birth control for the duration of the study
  • Additional criteria may apply

You may not qualify if:

  • Currently pregnant or breastfeeding
  • History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
  • Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
  • Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  • Have received electroconvulsive therapy treatment within the last 5 years
  • Have attempted suicide within the past 2 years
  • Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  • Have had a significant blood loss or blood donation with 60 days of screening
  • Additional criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alkermes Investigational Site

Jacksonville, Florida, 32256, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32806, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30308, United States

Location

Alkermes Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Alkermes Investigational Site

Staten Island, New York, 10305, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Eva Stroynowski
Organization
Alkermes
eva.stroynowski@alkermes.com
781-609-7000

Study Officials

  • Sanjeev Pathak, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 12, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 14, 2019

Results First Posted

March 27, 2019

Record last verified: 2019-08

Locations

CA(1)US(8)