This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Time frame: Baseline and 4 weeks for each stage
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Time frame: 4 weeks for each stage
Change From Baseline in 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.
Time frame: 4 weeks for each stage
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Alkermes Investigational Site
Tucson, Arizona, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
Fort Myers, Florida, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
St. Petersburg, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
...and 17 more locations
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."
Time frame: 4 weeks for each stage