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

Major Depressive Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381107
• Other study ID #: ALK33BUP-201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 16, 2011
• Last updated: August 18, 2011
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ALKS 5461
Sublingual administration once daily for 7 consecutive days.
• Placebo
Sublingual administration once daily for 7 consecutive days.

Locations

Country	Name	City	State
United States	Comprehensive NeuroScience, Inc.	Atlanta	Georgia
United States	Comprehensive NeuroScience, Inc.	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No