Aticrapant for Anhedonia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Instituto Goiano de Neuropsiquiatria, Goiania, Brazil
Anhedonia+3 More
Aticrapant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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

  • Anhedonia
  • Psychosis, Involutional

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Anhedonia

Study Objectives

1 Primary · 11 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-Åsberg 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
Day 43
Change from Baseline over Time in the Work Productivity and Activity Impairment (WPAI:D)
Day 57
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
Change from Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Short Form-Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) Over Time
Change from Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Social Functioning Short Form 8a Total Score Over Time
Day 43
Percentage of Participants with Remission of Depressive Symptoms Defined as a MADRS Total Score <=12 at Day 43
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

Other trials for Anhedonia

Trial Design

2 Treatment Groups

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

538 Total Participants · 2 Treatment Groups

Primary Treatment: Aticrapant · Has Placebo Group · Phase 3

Aticrapant
Drug
Experimental Group · 1 Intervention: Aticrapant · 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: Convenient Medical Center · Hialeah, FL
Photo of Hialeah 1Photo of florida 2Photo of florida 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Anhedonia
0 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,330 Total Patients Enrolled
1 Trials studying Anhedonia
830 Patients Enrolled for Anhedonia
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
705 Previous Clinical Trials
3,899,625 Total Patients Enrolled
1 Trials studying Anhedonia
830 Patients Enrolled for Anhedonia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a score of 20 or higher on the Hamilton Depression Rating Scale 17 item (HDRS-17) at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and 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.