A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Dis… (NCT06514742) | Clinical Trial Compass
TerminatedPhase 3
A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant
Stopped: Early study termination due to insufficient efficacy.
United States101 participantsStarted 2024-06-26
Plain-language summary
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).
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and double blind (DB) baseline
* Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features (DSM-5 296.22, 296.23, 296.32, or 296.33), based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 axis I disorders-clinical trials version (SCID-CT)
* Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to MDE module symptom Item 2) on the SCID-CT at screening
* Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose
* Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI) antidepressants at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, or desvenlafaxine at a stable dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatm…
What they're measuring
1
Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score