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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03188185




Registration number
NCT03188185
Ethics application status
Date submitted
9/06/2017
Date registered
15/06/2017

Titles & IDs
Public title
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Scientific title
A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
Secondary ID [1] 0 0
ALK5461-217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALKS 5461
Treatment: Drugs - ALKS 5461 Placebo

Experimental: ALKS 5461 - Sublingual tablets

Placebo comparator: ALKS 5461 Placebo - Sublingual tablets


Treatment: Drugs: ALKS 5461
Samidorphan + buprenorphine, administered sublingually

Treatment: Drugs: ALKS 5461 Placebo
Placebo tablet, administered sublingually
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
Timepoint [1] 0 0
Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale (MADRS) Response Rate
Timepoint [1] 0 0
Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary outcome [2] 0 0
Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate
Timepoint [2] 0 0
5 weeks for Stage 1, 6 weeks for Stage 2

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2020
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alkermes Investigational Site - Frankston
Recruitment hospital [2] 0 0
Alkermes Investigational Site - Noble Park
Recruitment hospital [3] 0 0
Alkermes Investigational Site - Richmond
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3174 - Noble Park
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sanjeev Pathak, MD
Address 0 0
Alkermes, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03188185