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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01381107
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
Alkermes, Inc.

June 16, 2011
June 27, 2011
August 23, 2011
May 2011
July 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01381107 on Archive Site
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ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)
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).
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Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Major Depressive Disorder
  • Drug: ALKS 5461
    Sublingual administration once daily for 7 consecutive days.
  • Drug: Placebo
    Sublingual administration once daily for 7 consecutive days.
  • Experimental: ALKS 5461 (ALKS 33 and buprenorphine)
    Intervention: Drug: ALKS 5461
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Alkermes, Inc.
Alkermes, Inc.
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Study Director: Richard Leigh-Pemberton, M.D. Medical Director
Alkermes, Inc.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP