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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
Pivotal Trial
Summary
This trial is testing aticaprant to see if it can help adults with major depressive disorder and anhedonia who haven't responded well to other antidepressants. Aticaprant works by blocking certain receptors in the brain to potentially improve depressive symptoms.
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.
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.
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.
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 ~ baseline up to day 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 57
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 43
Secondary study objectives
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 moreSide effects data
From 2017 Phase 2 trial • 163 Patients • NCT0221873629%
Diarrhea
22%
Headache
22%
Puritus
20%
Suicidal Ideation
13%
Rash
13%
Anxiety
13%
Depression
13%
Dizziness
9%
Pollakiuria
9%
Dry Skin
9%
Dry Mouth
9%
Insomnia
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%
Sinus congestion
4%
Irritability
4%
Malaise
4%
Hyperhidrosis
2%
Mood altered
2%
Initial insomnia
2%
Urinary track infeciton
2%
Tendon rupture
2%
Gastrointestinal disorder
2%
Syncope
2%
Viral infection
2%
Chest pain
2%
Costochondritis
2%
Herpes Zoster
2%
Back Pain
2%
Restlessness
2%
Libido decreased
2%
Blepharitis
2%
Panic attack
2%
Chest discomfort
2%
Anal pruritus
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
Common treatments for anhedonia, a core symptom of major depressive disorder, often involve the use of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). These medications work by increasing the levels of serotonin and norepinephrine in the brain, which can help improve mood and emotional regulation.
Aticaprant, a Kappa Opioid Receptor Antagonist, represents a different approach by blocking the kappa opioid receptors, which are believed to play a role in stress and dysphoria. This mechanism can potentially alleviate anhedonia by reducing the negative emotional states that contribute to the inability to experience pleasure.
Understanding these mechanisms is crucial for anhedonia patients as it helps tailor treatments that specifically target the underlying neurochemical pathways involved in their symptoms.
A pilot, open study of sertraline in outpatients with treatment-resistant depression (TRD) or with a history of TRD who responded but later relapsed.
A pilot, open study of sertraline in outpatients with treatment-resistant depression (TRD) or with a history of TRD who responded but later relapsed.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,401,660 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,979,687 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of major depression and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent [%] on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments.I am currently on an SSRI or SNRI for depression and it's working okay.My current treatment for depression, including ketamine or ECT, hasn't worked.I am currently on an SSRI or SNRI for depression and it's working well.My current depression and its treatment response are verified by an independent assessment.I've tried 5 or more antidepressants without success in my current depressive episode.My current antidepressant is not the first one I've used for my depression.I have been diagnosed with major depression without psychosis, first occurring before I was 55.My health is stable as confirmed by recent medical exams and tests.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Aticaprant
Awards:
This trial has 1 awards, including:- 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: NCT05550532 — Phase 3