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Aticaprant for Depression (VENTURA-2 Trial)

Verified 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
Currently receiving a SSRI or SNRI and tolerating well
Must not have
You have been diagnosed with HIV/AIDS
You have been diagnosed with Psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 57
Awards & highlights

VENTURA-2 Trial Summary

This trial will compare the antidepressant aticaprant with a placebo as treatment for adults with major depressive disorder and moderate to severe anhedonia who haven't responded to SSRI or SNRI therapy.

Who is the study for?
Adults with major depressive disorder (MDD) and moderate-to-severe anhedonia who haven't responded well to current SSRI or SNRI antidepressants. They must have a history of depression, be medically stable, and not have had significant improvement in their symptoms recently.Check my eligibility
What is being tested?
The trial is testing Aticaprant as an add-on treatment compared to a placebo. Participants will continue their current antidepressant therapy and either receive Aticaprant or a placebo to see if it better improves symptoms of depression.See study design
What are the potential side effects?
While specific side effects for Aticaprant are not listed here, common side effects for medications like this can include nausea, headache, dizziness, dry mouth, sleep disturbances, and sexual dysfunction.

VENTURA-2 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-2 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-Asberg Depression Rating Scale (MADRS) Total Score to Day 43
Secondary outcome measures
Change From Baseline Over Time in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Ability to Participate in Social Roles and Activities 8a (PROMIS-APS 8a)
Change From Baseline in DARS Total Score Over Time
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score to Day 43
+6 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-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AticaprantExperimental Treatment1 Intervention
Participants will receive Aticaprant 10 milligrams (mg) tablet orally, once daily for 42 days during double-blind (DB) treatment phase in addition to their current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the DB 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 tablet orally, once daily for 42 days during DB treatment phase in addition to their current antidepressant SSRI/SNRI therapy. Participants who will complete the DB 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
6,383,598 Total Patients Enrolled
2 Trials studying Anhedonia
1,038 Patients Enrolled for Anhedonia
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,195 Total Patients Enrolled
2 Trials studying Anhedonia
1,038 Patients Enrolled for Anhedonia

Media Library

Aticaprant Clinical Trial Eligibility Overview. Trial Name: NCT05550532 — Phase 3
Anhedonia Research Study Groups: Placebo, Aticaprant
Anhedonia Clinical Trial 2023: Aticaprant Highlights & Side Effects. Trial Name: NCT05550532 — Phase 3
Aticaprant 2023 Treatment Timeline for Medical Study. Trial Name: NCT05550532 — Phase 3
Anhedonia Patient Testimony for trial: Trial Name: NCT05550532 — Phase 3

Frequently Asked Questions

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

Are there any dangers to taking Aticaprant?

"There is both efficacy and safety data from Phase 3 clinical trials, so our team has rated the safety of aticaprant as a 3."

Answered by AI

Is this clinical trial being conducted at many different hospitals in North America?

"This study is currently being conducted at 21 different locations across North America, including Toronto, Colorado Springs, and Kingston. If you are interested in participating, it is recommended that you choose a location that is closest to you to minimize travel."

Answered by AI

What are the eligibility requirements for this clinical trial?

"This particular study is testing potential treatments for anhedonia in patients aged 18 to 74. Right now, the team is looking to enroll 830 people."

Answered by AI

Are adults of all ages being recruited for this experiment?

"According to the information available, adults aged 18 to 74 years old can enroll in this clinical trial. There are a total of 203 studies relating to people under the age of 18 and 985 for people over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Manhattan Behavioral Medicine
Revive Research Institute
Tandem Clinical Research - New York, NY
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+
What state do they live in?
California
Michigan
New York
Other

What questions have other patients asked about this trial?

Is this available in Buffalo NY?? Does it disqualify me to have more than one mental health diagnosis?, is this paid?
PatientReceived 1 prior treatment
How long do visits take? Will I be compensated? How long before I feel symptom relief?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

To see if it will help with my depression. I’ve used Prozac.and Wellbutrin in the past.
PatientReceived 1 prior treatment
I can only wonder what life without depression is like. Want to feel like my self want to try something different.
PatientReceived 1 prior treatment
I’ve tried numerous mental health drugs to no avail and am hoping this trial might be helpful.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Clarke Institute of Psychiatry: < 24 hours
  2. California Neuroscience Research: < 48 hours
  3. Revive Research Institute: < 48 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
2022. "A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05550532.
All > Mdd
~194 spots leftby Oct 2024
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