Clinical trial NCT01381107: ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: Atlanta
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Georgia
Study officials:
affiliation: Medical Director
name: Richard Leigh-Pemberton, M.D.
role: STUDY_DIRECTOR
References: