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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

VENTURA-LT Trial 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.

VENTURA-LT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

VENTURA-LT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 54 for reporting.

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 more
Secondary 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 more

Side effects data

From 2017 Phase 2 trial • 163 Patients • NCT02218736
29%
Diarrhea
22%
Headache
22%
Puritus
20%
Suicidal Ideation
13%
Anxiety
13%
Rash
13%
Depression
13%
Dizziness
9%
Dry Skin
9%
Pollakiuria
9%
Dry Mouth
9%
Insomnia
9%
Tinnitus
9%
Vission Blurred
9%
Constipation
7%
Nausea
7%
Dysuria
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%
Restlessness
2%
Tendon rupture
2%
Viral infection
2%
Syncope
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

VENTURA-LT 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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,468 Total Patients Enrolled
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
9 Previous Clinical Trials
1,459 Total Patients Enrolled

Media Library

Aticaprant Clinical Trial Eligibility Overview. Trial Name: NCT05518149 — Phase 3
Major Depressive Disorder Research Study Groups: Aticaprant 10 mg
Major Depressive Disorder Clinical Trial 2023: Aticaprant Highlights & Side Effects. Trial Name: NCT05518149 — Phase 3
Aticaprant 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518149 — Phase 3
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05518149 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic goal does this research hope to realize?

"The primary objective of this clinical trial, which will be evaluated over the course of 54 weeks, is to study the number of participants that experience sexual dysfunction as measured by the Arizona Sexual Experiences Scale (ASEX). Additionally, this trial will also measure secondary outcomes including the percentage of participants that experience remission of depressive symptoms over time, as well as changes in the Montgomery-asberg Depression Rating Scale (MADRS) total score and the Clinical Global Impression-Severity (CGI-S) total score over time."

Answered by AI

Has the FDA sanctioned Aticaprant for public use?

"There is pre-existing clinical evidence suggesting that Aticaprant is safe for human use, which is why it was given a score of 3."

Answered by AI

Are people of all ages being sought for this clinical trial?

"The age limit for participants in this study is 74 years old, provided they are also above 18 years old."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
Texas
Other
What site did they apply to?
NoesisPharma Research
North Texas Clinical Trials
Neurobehavioral Medicine Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

Poor results from drugs. Hoping this will help me! To get help and help others.
PatientReceived 2+ prior treatments
Tried multiple antidepressants. I am trying to find a treatment for my mdd.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a paid study? How long is the study? Do you think this will help? When will I be required to travel?
PatientReceived 1 prior treatment
How long before I would start? Am I being compensated?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
  1. North Texas Clinical Trials: < 24 hours
  2. R and H Clinical Research: < 24 hours
  3. NoesisPharma Research: < 24 hours
~409 spots leftby Oct 2025