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

This study has been completed.
Information provided by (Responsible Party):
Alkermes Identifier:
First received: June 16, 2011
Last updated: August 18, 2011
Last verified: August 2011

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).

Condition Intervention Phase
Major Depressive Disorder
Drug: ALKS 5461
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)

Resource links provided by NLM:

Further study details as provided by Alkermes:

Primary Outcome Measures:
  • The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.

Estimated Enrollment: 32
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 5461 (ALKS 33 and buprenorphine) Drug: ALKS 5461
Sublingual administration once daily for 7 consecutive days.
Placebo Comparator: Placebo Drug: Placebo
Sublingual administration once daily for 7 consecutive days.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

    1. A Hamilton Depression Rating Scale total score (HAM-D17) ≥14, and
    2. Less than 50% reduction in depressive symptom severity on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ), and
    3. Clinical Global Impression - Severity (CGI-S) score of ≥3.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01381107

United States, Florida
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33716
United States, Georgia
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States, 30328
Sponsors and Collaborators
Study Director: Richard Leigh-Pemberton, M.D. Medical Director
  More Information

No publications provided

Responsible Party: Alkermes Identifier: NCT01381107     History of Changes
Other Study ID Numbers: ALK33BUP-201
Study First Received: June 16, 2011
Last Updated: August 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on April 23, 2014