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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/NCT03188185
Registration number
NCT03188185
Ethics application status
Date submitted
9/06/2017
Date registered
15/06/2017
Date last updated
8/04/2021
Titles & IDs
Public title
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
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Scientific title
A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
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Secondary ID [1]
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ALK5461-217
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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 - 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
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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 the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
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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 Major Depressive Disorder (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 Stage 1, Baseline and 6 weeks for Stage 2
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Secondary outcome [1]
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Montgomery Asberg Depression Rating Scale (MADRS) Response Rate
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Assessment method [1]
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The percentage of subjects demonstrating a MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (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 Stage 1, Baseline and 6 weeks for Stage 2
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Secondary outcome [2]
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Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate
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Assessment method [2]
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The percentage of subjects achieving remission, defined as a subject with a score </= 10 at the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (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).the end of the efficacy period.
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Timepoint [2]
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5 weeks for Stage 1, 6 weeks for Stage 2
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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
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Minimum age
18
Years
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Maximum age
70
Years
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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
- 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
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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
12/06/2017
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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
5/03/2020
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Sample size
Target
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Accrual to date
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Final
278
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alkermes Investigational Site - Frankston
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Recruitment hospital [2]
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Alkermes Investigational Site - Noble Park
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Recruitment hospital [3]
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Alkermes Investigational Site - Richmond
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment postcode(s) [2]
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3174 - Noble Park
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Recruitment postcode(s) [3]
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3121 - Richmond
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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Arkansas
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California
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Florida
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Georgia
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United States of America
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Maryland
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Missouri
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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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Tennessee
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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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Washington
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Country [16]
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Puerto Rico
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State/province [16]
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San Juan
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
adults who have treatment refractory MDD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03188185
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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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03188185
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