Your session is about to expire
← Back to Search
Aticaprant for Depression (VENTURA-LT Trial)
Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-74 years old
BMI 18-40
Must not have
You have been diagnosed with Psychosis
You have been diagnosed with Substance Use Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 54
Awards & highlights
Summary
This trial is testing a new drug to see if it's safe and effective when used with current antidepressants to treat people with major depressive disorder.
Who is the study for?
This trial is for adults with Major Depressive Disorder who haven't had enough improvement after trying 1-3 antidepressants. They must have a certain score on a depression rating scale and meet specific diagnostic criteria without psychotic features. Employees of the study or those with allergies to aticaprant can't participate.Check my eligibility
What is being tested?
The trial tests Aticaprant's long-term safety and effectiveness when added to current SSRI or SNRI treatments in patients with depression. It aims to see if this combination helps people who didn't respond well to previous medications.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical reactions seen with antidepressants such as nausea, headaches, sleep disturbances, sexual dysfunction, and possibly unique risks associated with Aticaprant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 54
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 54
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Abnormal Body Mass Index (BMI)
Number of Participants with Abnormal Body Weight
Number of Participants with Abnormalities in Clinical Laboratory parameters
+7 moreSecondary outcome measures
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
Mental Depression
+3 moreSide effects data
From 2017 Phase 2 trial • 163 Patients • NCT0221873629%
Diarrhea
22%
Headache
22%
Puritus
20%
Suicidal Ideation
13%
Anxiety
13%
Rash
13%
Depression
13%
Dizziness
9%
Dry Mouth
9%
Insomnia
9%
Pollakiuria
9%
Dry Skin
9%
Tinnitus
9%
Vission Blurred
9%
Constipation
7%
Dysuria
7%
Nausea
7%
Fatigue
7%
Coordination Abnormal
7%
Disturbance in Attention
7%
Dizziness postural
7%
Non-cardiac chest pain
4%
Irritability
4%
Malaise
4%
Sinus congestion
4%
Hyperhidrosis
2%
Syncope
2%
Restlessness
2%
Viral infection
2%
Tendon rupture
2%
Urinary track infeciton
2%
Libido decreased
2%
Back Pain
2%
Panic attack
2%
Anal pruritus
2%
Blepharitis
2%
Chest discomfort
2%
Chest pain
2%
Costochondritis
2%
Gastrointestinal disorder
2%
Herpes Zoster
2%
Initial insomnia
2%
Mood altered
2%
Arthralgia
2%
Hypersomnia
2%
Asthenia
2%
Muscle twitching
2%
Nasopharyngitis
2%
Self-injurious ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
CERC-501
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aticaprant 10 mgExperimental Treatment1 Intervention
Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Major Depressive Disorder (MDD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). SSRIs work by increasing serotonin levels in the brain, while SNRIs increase both serotonin and norepinephrine levels.
These neurotransmitters play key roles in mood regulation. Adjunctive therapies like Aticaprant are being studied to further enhance the efficacy of SSRIs or SNRIs by targeting additional pathways involved in mood regulation.
Understanding these mechanisms is crucial for MDD patients as it allows for more personalized and effective treatment strategies, potentially leading to better management of depressive symptoms.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,383,453 Total Patients Enrolled
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
9 Previous Clinical Trials
1,459 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried at least one antidepressant for my current depression episode without enough improvement.I completed a specific study without stopping or changing my depression medication early.I have not followed my antidepressant treatment as prescribed.I completed a previous study without stopping or changing my depression medication early.I am not hospitalized and will start treatment as an outpatient.I have been diagnosed with major depression without psychosis.I've tried at least one antidepressant for my current depression episode without enough improvement.I am not hospitalized and will start treatment as an outpatient.I've tried 1-3 antidepressants for my current depression episode without enough improvement.I completed a previous study without stopping or changing my depression medication early.I am not hospitalized and will start treatment as an outpatient.I have been diagnosed with major depression without psychosis.Participants should not take any medications or food supplements that may interact with the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Aticaprant 10 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05518149 — Phase 3
Share this study with friends
Copy Link
Messenger