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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
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Secondary ID [1]
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ALK5461-205
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 5 weeks for each stage
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Secondary outcome [1]
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Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline and 5 weeks for each stage
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Secondary outcome [2]
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Remission Rate
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Assessment method [2]
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The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
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Timepoint [2]
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Baseline and 5 weeks for each stage
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Secondary outcome [3]
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Number of Subjects With Adverse Events (AEs)
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Assessment method [3]
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Timepoint [3]
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5 weeks for Stage 1 and 6 weeks for Stage 2
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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
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
385
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Alkermes Investigational Site - Brisbane
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Recruitment hospital [2]
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Alkermes Investigational Site - Towong
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Recruitment hospital [3]
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Alkermes Investigational Site - Frankston
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Recruitment hospital [4]
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Alkermes Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Recruitment postcode(s) [2]
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4066 - Towong
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alkermes, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy and safety of ALKS 5461.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02158533
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sanjeev Pathak, MD
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Address
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Alkermes, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02158533
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