A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
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| ClinicalTrials.gov Identifier: NCT02218008 |
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Recruitment Status :
Completed
First Posted : August 15, 2014
Results First Posted : March 27, 2019
Last Update Posted : August 14, 2019
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Sponsor:
Alkermes, Inc.
Information provided by (Responsible Party):
Alkermes, Inc.
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Brief Summary:
This study will evaluate the efficacy and safety of ALKS 5461.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: ALKS 5461 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 407 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study) |
| Study Start Date : | July 2014 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | October 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
| Experimental: High Dose |
Drug: ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Experimental: Low Dose |
Drug: ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Placebo Comparator: Placebo |
Drug: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
Primary Outcome Measures :
- Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) [ Time Frame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect ]The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
- Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]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.
- Change From Baseline to End of Treatment in the MADRS-10 [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]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.
Secondary Outcome Measures :
- Proportion of Patients Who Exhibited Treatment Response (MADRS-10) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]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 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.
- Remission Rate [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.
- Number of Subjects With Adverse Events (AEs) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a 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 an 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 their 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218008
Locations
| United States, Alabama | |
| Alkermes Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Alkermes Investigational Site | |
| Colton, California, United States, 92324 | |
| Alkermes Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| Alkermes Investigational Site | |
| Los Angeles, California, United States, 90024 | |
| Alkermes Investigational Site | |
| Oakland, California, United States, 94612 | |
| Alkermes Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Alkermes Investigational Site | |
| Pico Rivera, California, United States, 90660 | |
| Alkermes Investigational Site | |
| San Gabriel, California, United States, 91776 | |
| United States, Colorado | |
| Alkermes Investigational Site | |
| Colorado Springs, Colorado, United States, 80910 | |
| United States, Florida | |
| Alkermes Investigational Site | |
| Bradenton, Florida, United States, 34201 | |
| Alkermes Investigational Site | |
| Fort Myers, Florida, United States, 33912 | |
| Alkermes Investigational Site | |
| Melbourne, Florida, United States, 32901 | |
| Alkermes Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| Alkermes Investigational Site | |
| Oakland Park, Florida, United States, 33334 | |
| Alkermes Investigational Site | |
| Winter Haven, Florida, United States, 33880 | |
| United States, Georgia | |
| Alkermes Investigational Site | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Illinois | |
| Alkermes Investigational Site | |
| Hoffman Estates, Illinois, United States, 60169 | |
| United States, Mississippi | |
| Alkermes Investigational Site | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Alkermes Investigational Site | |
| Saint Charles, Missouri, United States, 63304 | |
| Alkermes Investigational Site | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Alkermes Investigational Site | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| Alkermes Investigational Site | |
| New York, New York, United States, 10168 | |
| United States, North Carolina | |
| Alkermes Investigational Site | |
| High Point, North Carolina, United States, 27265 | |
| United States, Ohio | |
| Alkermes Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Alkermes Investigational Site | |
| Portland, Oregon, United States, 97214 | |
| United States, Tennessee | |
| Alkermes Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Alkermes Investigational Site | |
| DeSoto, Texas, United States, 75115 | |
| Alkermes Investigational Site | |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Utah | |
| Alkermes Investigational Site | |
| Clinton, Utah, United States, 84015 | |
| United States, Washington | |
| Alkermes Investigational Site | |
| Bellevue, Washington, United States, 98007 | |
| Alkermes Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| Alkermes Investigational Site | |
| Spokane, Washington, United States, 99204 | |
| Canada | |
| Alkermes Investigational Site | |
| Gatineau, Canada, J8T 8J1 | |
| Alkermes Investigational Site | |
| Halifax, Canada, B3S 1M7 | |
| Alkermes Investigational Site | |
| Penticton, Canada, V2A 4M4 | |
| Alkermes Investigational Site | |
| Quebec, Canada, G3K 2P8 | |
| Germany | |
| Alkermes Investigational Site | |
| Berlin, Germany, 10245 | |
| Alkermes Investigational Site | |
| Berlin, Germany, 10629 | |
| Alkermes Investigational Site | |
| Hannover, Germany, 30159 | |
| Alkermes Investigational Site | |
| Oranienburg, Germany, 16515 | |
| Alkermes Investigational Site | |
| Schwerin, Germany, 19053 | |
| Alkermes Investigational Site | |
| Stralsund, Germany, 18439 | |
| Puerto Rico | |
| Alkermes Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Alkermes Investigational Site | |
| San Juan, Puerto Rico, 00926 | |
Sponsors and Collaborators
Alkermes, Inc.
Investigators
| Study Director: | Sanjeev Pathak, MD | Alkermes, Inc. |
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT02218008 |
| Other Study ID Numbers: |
ALK5461-207 |
| First Posted: | August 15, 2014 Key Record Dates |
| Results First Posted: | March 27, 2019 |
| Last Update Posted: | August 14, 2019 |
| Last Verified: | August 2019 |
Keywords provided by Alkermes, Inc.:
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Major depressive disorder (MDD) depression Alkermes ALKS 5461 samidorphan |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Depressive Disorder, Major |
Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms |