The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Aticaprant tablet will be administered orally.
Placebo tablet will be administered orally.
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, United States
IMA Clinical Research PC
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Advanced Research Center Inc
Anaheim, California, United States
CI Trials
Bellflower, California, United States
Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Change from baseline to Day 43 in MADRS total score will be reported.
Time frame: Baseline to Day 43
Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score
Change from baseline to Day 43 in DARS total score will be reported.
Time frame: Baseline to Day 43
Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score
Change from baseline to Day 43 in CSFQ-14 total score will be reported.
Time frame: Baseline to Day 43
Change From Baseline Over Time in MADRS Total Score
Change from baseline over time in the MADRS total score will be reported.
Time frame: For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31
Percentage of responders on Depressive Symptoms Scale, Defined as a Greater Than or Equal to (>=) 50 Percent (%) Improvement in MADRS Total Score From Baseline to Day 43
Percentage of responders on depressive symptoms scale, defined as a \>= 50 % improvement in MADRS total score from baseline to Day 43 will be reported.
Time frame: Baseline to Day 43
Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43
Percentage of participants with remission of depressive symptoms, defined as a MADRS total score \<=10 at Day 43 will be reported.
Time frame: Day 43
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Change from baseline to Day 43 in the PHQ-9 total score will be reported.
Time frame: Baseline to Day 43
Change From Baseline Over Time in DARS Total score.
Change from baseline over time in DARS total score will be reported.
Time frame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1).
Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported.
Time frame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
Percentage of participants with a score \< 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 will be reported.
Time frame: Day 43
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Behavioral Research Specialists LLC
Glendale, California, United States
Sun Valley Research Center
Imperial, California, United States
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Orange, California, United States
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San Jose, California, United States
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Temecula, California, United States
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