ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

NCT01381107 | Completed Phase 1 DMC

• 1 other identifier: ALK33BUP-201
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461)

  Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.

  7 days

Study Arms (2)

ALKS 5461 (ALKS 33 and buprenorphine)

EXPERIMENTAL

Drug: ALKS 5461

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALKS 5461 DRUG

Sublingual administration once daily for 7 consecutive days.

ALKS 5461 (ALKS 33 and buprenorphine)

Placebo DRUG

Sublingual administration once daily for 7 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between 18 and 65 years of age, inclusive.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD.
• Current episode lasting ≥8 weeks prior to screening with an inadequate/partial response to an adequate trial (defined as at least 8 weeks) of a stable dose of an SSRI or SNRI. Inadequate/partial response is defined as:
• A Hamilton Depression Rating Scale total score (HAM-D17) ≥14, and
• Less than 50% reduction in depressive symptom severity on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ), and
• Clinical Global Impression - Severity (CGI-S) score of ≥3.

You may not qualify if:

• Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder.
• A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
• Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode.
• The use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 (prescription medications, over-the-counter \[OTC\] medications, or dietary supplements) within 30 days before dosing.
• Have received electroconvulsive therapy during the current MDD episode.
• Pose current suicide risk as confirmed by the Columbia Suicide Severity Rating Scale (C SSRS).
• History of intolerance or hypersensitivity to buprenorphine.
• History of allergy or hypersensitivity to opioid antagonists (eg, naltrexone, naloxone) or quinine.

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (2)

Comprehensive NeuroScience, Inc.

St. Petersburg, Florida, 33716, United States

Location

Comprehensive NeuroScience, Inc.

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Richard Leigh-Pemberton, M.D.

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 27, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

US (2)