A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Titration Schedule 1

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

Sublingual tablet taken once daily

Titration Schedule 2

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

Sublingual tablet taken once daily

Interventions

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ALKS 5461

Sublingual tablet taken once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No