Aticaprant for Psychosis, Involutional

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Centrum Badań Klinicznych PI-House sp. z o.o., Gdansk, Poland
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 assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).

Eligible Conditions

  • Psychosis, Involutional

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Psychosis, Involutional

Study Objectives

9 Primary · 6 Secondary · Reporting Duration: Week 54

Week 54
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
Up to Week 54
Number of Participants With Adverse Events of Special Interest (AESI)
Number of Participants with Abnormal Body Mass Index (BMI)
Number of Participants with Abnormal Body Weight
Number of Participants with Abnormalities in Clinical Laboratory Values
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of Participants with Adverse Events (AEs)
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Number of Participants with Sexual Dysfunction as Measured by Arizona Sexual Experiences Scale (ASEX)
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 54
Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
Percentage of Participants with Remission of Depressive Symptoms Over Time

Trial Safety

Safety Progress

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

Other trials for Psychosis, Involutional

Trial Design

1 Treatment Group

Aticaprant 10 mg
1 of 1
Experimental Treatment

960 Total Participants · 1 Treatment Group

Primary Treatment: Aticaprant · No Placebo Group · Phase 3

Aticaprant 10 mg
Drug
Experimental Group · 1 Intervention: Aticaprant · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 54
Closest Location: Loma Linda University Health Care · Loma Linda, CA
Photo of california 1Photo of california 2Photo of california 3
2008First Recorded Clinical Trial
0 TrialsResearching Psychosis, Involutional
9 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,325,908 Total Patients Enrolled
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
6 Previous Clinical Trials
1,094 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You should not take any medication or food supplements.
You have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression.
You have recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT).
You have a history of depression and you have a score of 20 or higher on the Hamilton Depression Rating Scale (HDRS)-17 at the first and second screening interviews.

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.