Major Depressive Disorder Clinical Trial
Official title:
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
NCT number | NCT02158533 |
Other study ID # | ALK5461-205 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2015 |
Verified date | August 2019 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the efficacy and safety of ALKS 5461.
Status | Completed |
Enrollment | 385 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Alkermes Investigational Site | Brisbane | Queensland |
Australia | Alkermes Investigational Site | Frankston | Victoria |
Australia | Alkermes Investigational Site | Melbourne | Victoria |
Australia | Alkermes Investigational Site | Towong | Queensland |
Canada | Alkermes Investigational Site | Gatineau | Quebec |
Canada | Alkermes Investigational Site | Penticton | British Columbia |
Canada | Alkermes Investigational Site | Quebec | |
United States | Alkermes Investigational Site | Allentown | Pennsylvania |
United States | Alkermes, Investigational Site | Alpharetta | Georgia |
United States | Alkermes Investigational Site | Austin | Texas |
United States | Alkermes Investigational Site | Baltimore | Maryland |
United States | Alkermes Investigational Site | Baltimore | Maryland |
United States | Alkermes Investigational Site | Berlin | New Jersey |
United States | Alkermes Investigational Site | Birmingham | Alabama |
United States | Alkermes Investigational Site | Brooklyn | New York |
United States | Alkermes Investigational Site | Canton | Ohio |
United States | Alkermes Investigational Site | Carson | California |
United States | Alkermes Investigational Site | Chicago | Illinois |
United States | Alkermes Investigational Site | Coral Springs | Florida |
United States | Alkermes Investigational Site | Dayton | Ohio |
United States | Alkermes Investigational Site | Decatur | Georgia |
United States | Alkermes Investigational Site | Gainesville | Florida |
United States | Alkermes Investigational Site | Hartford | Connecticut |
United States | Alkermes Investigational Site | Houston | Texas |
United States | Alkermes Investigational Site | Joliet | Illinois |
United States | Alkermes Investigational Site | Lauderhill | Florida |
United States | Alkermes Investigational Site | Lincoln | Rhode Island |
United States | Alkermes Investigational Site | Media | Pennsylvania |
United States | Alkermes Investigational Site | Middleton | Wisconsin |
United States | Alkermes Investigational Site | Mount Kisco | New York |
United States | Alkermes Investigational Site | National City | California |
United States | Alkermes Investigational Site | New York | New York |
United States | Alkermes Investigational Site | Newburgh | Indiana |
United States | Alkermes Investigational Site | Norwich | Connecticut |
United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
United States | Alkermes Investigational Site | Orange | California |
United States | Alkermes Investigational Site | Orlando | Florida |
United States | Alkermes Investigational Site | Owensboro | Kentucky |
United States | Alkermes Investigational Site | Philadelphia | Pennsylvania |
United States | Alkermes Investigational Site | San Antonio | Texas |
United States | Alkermes Investigational Site | Sherman Oaks | California |
United States | Alkermes Investigational Site | Skokie | Illinois |
United States | Alkermes Investigational Site | Staten Island | New York |
United States | Alkermes Investigational Site | Torrance | California |
United States | Alkermes Investigational Site | Tucson | Arizona |
United States | Alkermes Investigational Site | Upland | California |
United States | Alkermes Investigational Site | Valparaiso | Indiana |
United States | Alkermes Investigational Site | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 5 weeks for each stage | |
Secondary | 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). | Baseline and 5 weeks for each stage | |
Secondary | Remission Rate | The proportion of subjects achieving remission, defined as a MADRS-10 score of | Baseline and 5 weeks for each stage | |
Secondary | Number of Subjects With Adverse Events (AEs) | 5 weeks for Stage 1 and 6 weeks for Stage 2 |
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