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

NCT ID: NCT01381107

Last Updated: 2011-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-07-31

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

ALKS 5461 (ALKS 33 and buprenorphine)

Group Type: EXPERIMENTAL

ALKS 5461

Intervention Type: DRUG

Sublingual administration once daily for 7 consecutive days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sublingual administration once daily for 7 consecutive days.

Interventions

ALKS 5461

Sublingual administration once daily for 7 consecutive days.

Intervention Type: DRUG

Placebo

Sublingual administration once daily for 7 consecutive days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Leigh-Pemberton, M.D.

Role: STUDY_DIRECTOR

Medical Director

Locations

Comprehensive NeuroScience, Inc.

St. Petersburg, Florida, United States

Comprehensive NeuroScience, Inc.

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

ALK33BUP-201

Identifier Type: -

Identifier Source: org_study_id