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Aticaprant for Depression (VENTURA-7 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
Currently receiving and tolerating one of the specified SSRI or SNRI antidepressants at a stable dose for at least 6 weeks
Have symptoms of anhedonia confirmed by SCID-CT at screening
Must not have
No response to 2 or more consecutive antidepressant treatments in the current episode of depression
Received vagal nerve stimulation, deep brain stimulation, ketamine, esketamine, or electroconvulsive therapy in the current episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for db treatment phase: baseline (day 1), up to day 43; for ol treatment phase: baseline (day 43), up to week 31
Awards & highlights
Pivotal Trial

Summary

This trial is testing if aticaprant can help adults with major depressive disorder who haven't responded well to current antidepressants. The medication works by targeting brain chemicals to improve mood and pleasure.

Who is the study for?
This trial is for adults with Major Depressive Disorder who still feel a significant lack of pleasure (anhedonia) despite being on current antidepressants like SSRIs or SNRIs. Participants should have an inadequate response to these treatments.
What is being tested?
The study tests Aticaprant, given alongside standard antidepressants, against a placebo (a substance with no active drug). It aims to see if Aticaprant can better improve symptoms of depression in those not helped enough by their current medication.
What are the potential side effects?
While the specific side effects are not listed here, typical side effects may include nausea, headache, dizziness, dry mouth, sleep disturbances or changes in appetite. Some people might experience no side effects at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking a specific antidepressant without side effects for over 6 weeks.
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I have been diagnosed with a loss of interest or pleasure in most activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My depression hasn't improved after trying 2 different antidepressants.
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I have received treatments like vagal nerve or deep brain stimulation, or ketamine therapy recently.
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I have not had thoughts of harming myself or others in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for db treatment phase: baseline (day 1), up to day 43; for ol treatment phase: baseline (day 43), up to week 31
This trial's timeline: 3 weeks for screening, Varies for treatment, and for db treatment phase: baseline (day 1), up to day 43; for ol treatment phase: baseline (day 43), up to week 31 for reporting.

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 to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Secondary study objectives
Change From Baseline Over Time in DARS Total score.
Change From Baseline Over Time in MADRS Total Score
Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1).
+6 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%
Tendon rupture
2%
Mood altered
2%
Initial insomnia
2%
Urinary track infeciton
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
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aticaprant
2022
Completed Phase 3
~450

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,553 Total Patients Enrolled
4 Trials studying Anhedonia
2,142 Patients Enrolled for Anhedonia
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,580 Total Patients Enrolled
4 Trials studying Anhedonia
2,142 Patients Enrolled for Anhedonia
~233 spots leftby Jun 2026
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