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Aticaprant + Antidepressant for Depression (VENTURA-5 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
Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features
Be between 18 and 65 years old
Must not have
Homicidal ideation/intent or suicidal ideation with intent to act within 3 months prior to screening
Has had no response to 2 or more consecutive antidepressant treatments in the current episode of depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 16 (db baseline) up to 2 years 2 months in the db phase
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if aticaprant is effective in preventing the return of depression symptoms when added to antidepressant therapy in individuals with major depressive disorder who have already responded well to aticaprant treatment

Who is the study for?
This trial is for adults with Major Depressive Disorder who still feel a loss of interest and pleasure despite being on antidepressants. They should have had some improvement with aticaprant added to their treatment. People can't join if they have other mental health conditions, are pregnant or breastfeeding, or are at risk of suicide.
What is being tested?
The study tests whether adding Aticaprant to regular antidepressant therapy (SSRI or SNRI) prevents the return of depression symptoms better than a placebo in those who've seen initial improvements but still struggle with anhedonia.
What are the potential side effects?
Possible side effects include gastrointestinal issues like nausea and constipation, headaches, dizziness, changes in appetite or weight, fatigue, and potential impacts on mood such as increased anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with depression without experiencing psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had thoughts of harming myself or others in the last 3 months.
Select...
My depression hasn't improved after trying 2 different antidepressants.
Select...
I am able to understand and follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 16 (db baseline) up to 2 years 2 months in the db phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 16 (db baseline) up to 2 years 2 months in the db phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse
Secondary study objectives
Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score
Change from DB Baseline in PHQ-9 Total Score
Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time
+10 more

Side effects data

From 2017 Phase 2 trial • 163 Patients • NCT02218736
29%
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%
Gastrointestinal disorder
2%
Syncope
2%
Tendon rupture
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
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,401,708 Total Patients Enrolled
4 Trials studying Anhedonia
2,098 Patients Enrolled for Anhedonia
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,979,735 Total Patients Enrolled
4 Trials studying Anhedonia
2,098 Patients Enrolled for Anhedonia
~440 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
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