A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188185
• Other study ID #: ALK5461-217
• Status: Completed
• Phase: Phase 3
• Start date: June 12, 2017
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2021
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: March 5, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have a Major Depressive Disorder (MDD) primary diagnosis
• Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
• Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
• Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
• Additional criteria may apply

Exclusion Criteria:

• Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
• Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
• Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
• Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
• Has been hospitalized for MDD within 3 months before screening
• Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
• Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
• Has a significant risk for suicide
• Has a positive breath alcohol test at screening
• Has a positive test for drugs of abuse at screening or visit 2
• Is pregnant, planning to become pregnant, or is breastfeeding during the study
• Additional criteria may apply

Related Conditions & MeSH terms

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

Intervention

Drug:
• ALKS 5461
Samidorphan + buprenorphine, administered sublingually
• ALKS 5461 Placebo
Placebo tablet, administered sublingually

Locations

Country	Name	City	State
Australia	Alkermes Investigational Site	Frankston	Victoria
Australia	Alkermes Investigational Site	Noble Park	Victoria
Australia	Alkermes Investigational Site	Richmond	Victoria
Puerto Rico	Alkermes Investigational Site	San Juan
Puerto Rico	Alkermes Investigational Site	San Juan
United States	Alkermes Investigational Site	Allentown	Pennsylvania
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigative Site	Bellevue	Washington
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Decatur	Georgia
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Hollywood	Florida
United States	Alkermes Investigational Site	Jacksonville	Florida
United States	Alkermes Investigational Site	Jamaica	New York
United States	Alkermes Investigational Site	Lauderhill	Florida
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Los Alamitos	California
United States	Alkermes Investigational Site	Memphis	Tennessee
United States	Alkermes Investigational Site	Mount Kisco	New York
United States	Alkermes Investigational Site	O'Fallon	Missouri
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Orlando	Florida
United States	Alkermes Investigative Site	Palm Bay	Florida
United States	Alkermes Investigational Site	Pico Rivera	California
United States	Alkermes Investigational Site	Pikesville	Maryland
United States	Alkermes Investigational Site	Redlands	California
United States	Alkermes Investigational Site	Santa Ana	California
United States	Alkermes Investigational Site	Sherman Oaks	California
United States	Alkermes Investigational Site	Temecula	California
United States	Alkermes Investigational Site	Tucson	Arizona
United States	Alkermes Investigative Site	Upland	California
United States	Alkermes Investigational Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores	The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (MDD) symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.	Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary	Montgomery Asberg Depression Rating Scale (MADRS) Response Rate	The percentage of subjects demonstrating a MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (MDD) symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).	Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary	Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate	The percentage of subjects achieving remission, defined as a subject with a score	5 weeks for Stage 1, 6 weeks for Stage 2