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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02158533




Registration number
NCT02158533
Ethics application status
Date submitted
5/06/2014
Date registered
9/06/2014
Date last updated
14/08/2019

Titles & IDs
Public title
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Scientific title
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Secondary ID [1] 0 0
ALK5461-205
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 - High Dose ALKS 5461
Treatment: Drugs - Low Dose ALKS 5461
Treatment: Drugs - Placebo

Experimental: High Dose -

Experimental: Low Dose -

Placebo Comparator: Placebo -


Treatment: Drugs: High Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Treatment: Drugs: Low Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Treatment: Drugs: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score - The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of 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.
Timepoint [1] 0 0
Baseline and 5 weeks for each stage
Secondary outcome [1] 0 0
Proportion of Patients Who Exhibited Treatment Response (MADRS-10) - The proportion of subjects demonstrating MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of 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).
Timepoint [1] 0 0
Baseline and 5 weeks for each stage
Secondary outcome [2] 0 0
Remission Rate - The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
Timepoint [2] 0 0
Baseline and 5 weeks for each stage
Secondary outcome [3] 0 0
Number of Subjects With Adverse Events (AEs)
Timepoint [3] 0 0
5 weeks for Stage 1 and 6 weeks for Stage 2

Eligibility
Key inclusion criteria
- Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

- Agree to use an acceptable method of contraception for the duration of the study

- Have a Major Depressive Disorder (MDD) primary diagnosis

- Have no more than 2 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
- Have a current primary Axis-I disorder other than MDD

- Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
antagonists (eg, naloxone, naltrexone) within 14 days

- Have received electroconvulsive therapy treatment within the last 2 years or received
more than one course of electroconvulsive treatment during lifetime

- Have attempted suicide within the past 2 years

- Have a positive test for drugs of abuse

- Are pregnant, planning to become pregnant, or breastfeeding

- Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
antagonists (eg, naltrexone, naloxone)

- Have had a significant blood loss or blood donation within 60 days

- 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)
QLD,VIC
Recruitment hospital [1] 0 0
Alkermes Investigational Site - Brisbane
Recruitment hospital [2] 0 0
Alkermes Investigational Site - Towong
Recruitment hospital [3] 0 0
Alkermes Investigational Site - Frankston
Recruitment hospital [4] 0 0
Alkermes Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
4066 - Towong
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kentucky
Country [10] 0 0
United States of America
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Maryland
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New Jersey
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New York
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Wisconsin
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec

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 and safety of ALKS 5461.
Trial website
https://clinicaltrials.gov/show/NCT02158533
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