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Aticaprant for Major Depressive Disorder (VENTURA-1 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
Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for 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). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 57
Awards & highlights

VENTURA-1 Trial Summary

This trial will compare the effectiveness of aticaprant vs. placebo as an addition to current antidepressant therapy in adults with major depressive disorder who have moderate-to-severe anhedonia.

Who is the study for?
Adults with major depressive disorder and moderate-to-severe anhedonia not responding well to current SSRI or SNRI antidepressants. They must have been on a stable dose for at least 6 weeks, have no history of seizures or recent suicidal behavior, and cannot have certain other mental health diagnoses like bipolar disorder or substance use disorders.Check my eligibility
What is being tested?
The trial is testing Aticaprant as an add-on treatment to see if it improves symptoms in patients who haven't responded enough to their current antidepressant therapy. Participants will either receive Aticaprant or a placebo alongside their usual medication.See study design
What are the potential side effects?
While the specific side effects of Aticaprant are not listed here, common side effects from similar medications may include nausea, headache, dizziness, dry mouth, sleep disturbances, and changes in appetite or weight.

VENTURA-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My health is stable based on recent exams and tests.
Select...
I have been diagnosed with major depression without psychosis, first occurring before I was 55.

VENTURA-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Day 43
Secondary outcome measures
Change from Baseline in DARS Total Score Over Time
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score to Day 43
Change from Baseline in MADRS Total Score over Time
+7 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%
Tendon rupture
2%
Viral infection
2%
Syncope
2%
Restlessness
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-1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AticaprantExperimental Treatment1 Intervention
Participants will receive aticaprant tablets orally once daily for 42 days during double-blind treatment phase in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally once daily for 42 days during double-blind treatment phase in addition to their current antidepressant (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,814 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,411 Total Patients Enrolled

Media Library

Major Depressive Disorder Research Study Groups: Aticaprant, Placebo

Frequently Asked Questions

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

Can people over the age of 30 participate in this research project?

"The age range that this study is looking for are patients aged 18 to 74. Out of the 1205 total trials, 206 were related to treatments for those under 18 and 999 focused on care for elderly patients over 65 years old."

Answered by AI

Are there any inclusionary or exclusionary criteria for this experiment?

"This clinical trial is for people aged 18 to 74 who have anhedonia. To be eligible, patients must also meet the following criteria: Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline, Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for 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-"

Answered by AI

In how many different medical institutions is this research project being conducted?

"Bioscience Research LLC in Mount Kisco, New york, Irvine Clinical Research in Irvine, California, and Research Network America in Berwyn, Illinois are the primary locations for this trial. In addition, there are 48 other research sites."

Answered by AI

How many participants will this research project be able to accommodate?

"In order to begin this clinical trial, 538 eligible patients must enroll. The specified inclusion criteria narrows the pool of potential participants. However, those that do qualify can take part in the study at Bioscience Research LLC located in Mount Kisco, New york and Irvine Clinical Research situated in Irvine, California."

Answered by AI

Can people still sign up for this experiment?

"Correct, the information on clinicaltrials.gov does show that this particular trial is still recruiting patients. The listing for the trial was first posted on June 22nd, 2022 and was last updated on November 9th, 2022. This specific trial is looking to enroll 538 patients at 48 different locations."

Answered by AI

When might Aticrapant be available for general use?

"There is some evidence from past clinical trials to support the efficacy of Aticrapant, as well as data collected from multiple rounds of testing that suggest it is safe. We have given it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Fieve Clinical Research, Inc.
Suburban Research Associates
North Texas Clinical Trials
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?

I’m depressed all the time. Trazadone seraquil Lexapro thorzine. I’m tired of being depressed and unmotivated.
PatientReceived no prior treatments
I'm looking for something that works better with what I'm taking now? Sometimes my current antidepressants do not work completely. I am unmotivated and depressed.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Will you provide transportation? Do I get paid for this? How much and how long?
PatientReceived 2+ prior treatments
Is there compensation ? How long does trial last?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of Pennsylvania - Perelman School of Medicine: < 48 hours
  2. University of Arizona: < 48 hours
  3. Northwest Clinical Research Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
2022. "A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05455684.
All > Depression Los Angeles
~83 spots leftby Sep 2024
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