A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

Phase 3CompletedNCT02158546

Alkermes, Inc.447 enrolled

Overview

This study will evaluate the efficacy and safety of ALKS 5461.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

447

Conditions

Major Depressive Disorder

Interventions

ALKS 5461DRUG

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

PlaceboDRUG

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive * Agree to use an acceptable method of contraception for the duration of the study * Have a Major Depressive Disorder (MDD) primary diagnosis * Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE) * Additional criteria may apply Exclusion Criteria: * Have a current primary Axis-I disorder other than MDD * Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime * Have attempted suicide within the past 2 years * Have a positive test for drugs of abuse * Are pregnant, planning to become pregnant, or breastfeeding * 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 within 60 days * Additional criteria may apply

Locations (58)

Outcomes

Primary Outcomes

Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

Time frame: Baseline and week 6

Secondary Outcomes

Proportion of Patients Who Exhibited Treatment Response (MADRS-10)

The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 6).

Time frame: 6 weeks

Remission Rate

The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤ 10 at the end of the efficacy period.

Time frame: 6 weeks

Number of Subjects With Adverse Events (AEs)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Bellflower, California, United States

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Beverly Hills, California, United States

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Glendale, California, United States

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Los Alamitos, California, United States

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Orange, California, United States

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Redlands, California, United States

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Temecula, California, United States

Alkermes Investigational Site

Washington D.C., District of Columbia, United States

Alkermes Investigational Site

Hallandale, Florida, United States

...and 48 more locations