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
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
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: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 54
Closest Location: Loma Linda University Health Care · Loma Linda, CA
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 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.
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