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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, Inc. 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)

Further study details as provided by Alkermes, Inc.:

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 ]
    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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Alkermes, Inc.
Study Director: Richard Leigh-Pemberton, M.D. Medical Director
  More Information

Responsible Party: Alkermes, Inc. Identifier: NCT01381107     History of Changes
Other Study ID Numbers: ALK33BUP-201
Study First Received: June 16, 2011
Last Updated: August 18, 2011

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 18, 2017