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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03188185
Ethics application status
Date submitted
9/06/2017
Date registered
15/06/2017
Date last updated
31/03/2020

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 in the Montgomery Asberg Depression Rating Scale (MADRS) scores
Timepoint [1] 0 0
11 weeks
Secondary outcome [1] 0 0
Average differences in change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores
Timepoint [1] 0 0
11 weeks
Secondary outcome [2] 0 0
Montgomery Asberg Depression Rating Scale (MADRS) response - >/= 50% reduction in MADRS score
Timepoint [2] 0 0
11 weeks
Secondary outcome [3] 0 0
Montgomery Asberg Depression Rating Scale (MADRS) remission - MADRS score </= 10
Timepoint [3] 0 0
11 weeks

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
adults who have treatment refractory MDD.
Trial website
https://clinicaltrials.gov/show/NCT03188185
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

Summary results
Other publications