Clinical trial NCT03188185: A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Official title: A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Alkermes
Major Depressive Disorder
Treatment Refractory MDD
ALKS 5461
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
timeFrame: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) Response Rate
timeFrame: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
measure: Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate
timeFrame: 5 weeks for Stage 1, 6 weeks for Stage 2
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Los Alamitos
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: Redlands
country: United States
facility: Alkermes Investigational Site
state: California
city: Santa Ana
country: United States
facility: Alkermes Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Alkermes Investigational Site
state: California
city: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Upland
country: United States
facility: Alkermes Investigative Site
state: California
city: Hollywood
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Palm Bay
country: United States
facility: Alkermes Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Pikesville
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: O'Fallon
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: Mount Kisco
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Woodstock
country: United States
facility: Alkermes Investigational Site
state: Vermont
city: Bellevue
country: United States
facility: Alkermes Investigative Site
state: Washington
city: Frankston
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Noble Park
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Richmond
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: