Aticaprant for Psychosis, Involutional

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD, Sofia, Bulgaria
Psychosis, Involutional+3 More
Aticaprant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Eligible Conditions

  • Psychosis, Involutional
  • Anhedonia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline up to Day 57

Baseline to Day 43
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score to Day 43
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 43
Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score to Day 43
Percentage of Responders on Depressive Symptoms Scale from Baseline to Day 43 as Assessed by MADRS Total Score
Day 57
Change From Baseline Over Time in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Ability to Participate in Social Roles and Activities 8a (PROMIS-APS 8a)
Change From Baseline in DARS Total Score Over Time
Change From Baseline in MADRS Total Score over Time
Change from Baseline in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) Over Time
Day 43
Percentage of Participants With Remission of Depressive Symptoms at Day 43 as Assessed by MADRS Total Score
Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Aticaprant
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

830 Total Participants · 2 Treatment Groups

Primary Treatment: Aticaprant · Has Placebo Group · Phase 3

Aticaprant
Drug
Experimental Group · 1 Intervention: Aticaprant · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to day 57
Closest Location: University of Alabama at Birmingham · Birmingham, AL
Photo of university of alabama at birmingham  1Photo of university of alabama at birmingham  2Photo of university of alabama at birmingham  3
1991First Recorded Clinical Trial
0 TrialsResearching Psychosis, Involutional
1066 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of major depression and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent [%] on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.