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-3 Study)
NCT number | NCT02158546 |
Other study ID # | ALK5461-206 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2015 |
Verified date | May 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 | 447 |
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 |
---|---|---|---|
Bulgaria | Alkermes Investigational Site | Bourgas | |
Bulgaria | Alkermes Investigational Site | Kazanlak | |
Bulgaria | Alkermes Investigational Site | Sofia | |
Bulgaria | Alkermes Investigational Site | Sofia | |
Bulgaria | Alkermes Investigational Site | Sofia | |
Bulgaria | Alkermes Investigational Site | Varna | |
Bulgaria | Alkermes Investigational Site | Veliko Tarnovo | |
Bulgaria | Alkermes Investigational Site | Vratza | |
United States | Alkermes Investigational Site | Albuquerque | New Mexico |
United States | Alkermes Investigational Site | Atlanta | Georgia |
United States | Alkermes Investigational Site | Beachwood | Ohio |
United States | Alkermes Investigational Site | Bellevue | Washington |
United States | Alkermes Investigational Site | Bellflower | California |
United States | Alkermes Investigational Site | Beverly Hills | California |
United States | Alkermes Investigational Site | Brockton | Massachusetts |
United States | Alkermes Investigational Site | Charleston | South Carolina |
United States | Alkermes Investigational Site | Charlotte | North Carolina |
United States | Alkermes Investigational Site | Cherry Hill | New Jersey |
United States | Alkermes Investigational Site | Chicago | Illinois |
United States | Alkermes Investigational Site | Cincinnati | Ohio |
United States | Alkermes Investigational Site | Cincinnati | Ohio |
United States | Alkermes Investigational Site | Dallas | Texas |
United States | Alkermes Investigational Site | Dallas | Texas |
United States | Alkermes Investigational Site | Edgewood | Kentucky |
United States | Alkermes Investigational Site | Glendale | California |
United States | Alkermes Investigational Site | Hallandale Beach | Florida |
United States | Alkermes Investigational Site | Hialeah | Florida |
United States | Alkermes Investigational Site | Houston | Texas |
United States | Alkermes Investigational Site | Indianapolis | Indiana |
United States | Alkermes Investigational Site | Jacksonville | Florida |
United States | Alkermes Investigational Site | Jamaica | New York |
United States | Alkermes Investigational Site | Kansas City | Missouri |
United States | Alkermes Investigational Site | Lafayette | Indiana |
United States | Alkermes Investigational Site | Leesburg | Florida |
United States | Alkermes Investigational Site | Little Rock | Arkansas |
United States | Alkermes Investigational Site | Los Alamitos | California |
United States | Alkermes Investigational Site | Maitland | Florida |
United States | Alkermes Investigational Site | Mason | Ohio |
United States | Alkermes Investigational Site | Memphis | Tennessee |
United States | Alkermes Investigational Site | Middleburg Heights | Ohio |
United States | Alkermes Investigational Site | New York | New York |
United States | Alkermes Investigational Site | O'Fallon | Missouri |
United States | Alkermes Investigational Site | Oak Brook | Illinois |
United States | Alkermes Investigational Site | Orange | California |
United States | Alkermes Investigational Site | Philadelphia | Pennsylvania |
United States | Alkermes Investigational Site | Portland | Oregon |
United States | Alkermes Investigational Site | Redlands | California |
United States | Alkermes Investigational Site | Saint Louis | Missouri |
United States | Alkermes Investigational Site | Salem | Oregon |
United States | Alkermes Investigational Site | Staten Island | New York |
United States | Alkermes Investigational Site | Sugar Land | Texas |
United States | Alkermes Investigational Site | Tampa | Florida |
United States | Alkermes Investigational Site | Temecula | California |
United States | Alkermes Investigational Site | Vernon Hills | Illinois |
United States | Alkermes Investigational Site | Washington | District of Columbia |
United States | Alkermes Investigational | Washington DC | Maryland |
United States | Alkermes Investigational Site | Watertown | Massachusetts |
United States | Alkermes Investigational Site | Waukesha | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States, Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to End of Treatment (Week 6) 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 week 6 | |
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 6). | 6 weeks | |
Secondary | Remission Rate | The proportion of subjects achieving remission, defined as a MADRS-10 score of = 10 at the end of the efficacy period. | 6 weeks | |
Secondary | Number of Subjects With Adverse Events (AEs) | 6 weeks |
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