What side effects are associated with this type of intervention?

Common treatments for anhedonia, particularly those involving antidepressants like SSRIs and SNRIs, often include side effects such as gastrointestinal issues (e.g., nausea, diarrhea), dizziness, and sexual dysfunction (e.g., anorgasmia). In the context of adjunctive therapies like Aticaprant, which is a Kappa Opioid Receptor Antagonist, specific side effects are not detailed in the provided context, but similar treatments may include side effects like nausea, headache, and somnolence. It is important to discuss with a healthcare provider to understand the full range of potential side effects and their management.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting anhedonia. However, treatments for major depressive disorder (MDD) that may alleviate anhedonia include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Aticaprant, a Kappa Opioid Receptor Antagonist, is being studied as an adjunctive therapy for MDD with moderate to severe anhedonia, but it has not yet received FDA approval. Other drugs like agomelatine have shown effectiveness in improving anhedonia in clinical studies, though they are not specifically approved for this symptom by the FDA.

What other types of research exist?

Promising novel alternatives to Aticaprant for treating anhedonia in MDD patients include: 1) Esketamine (NMDA receptor antagonist) - already approved for treatment-resistant depression and showing potential for anhedonia. 2) Psilocybin (serotonin receptor agonist) - undergoing clinical trials for MDD with promising results. 3) Brexanolone (GABA-A receptor modulator) - approved for postpartum depression, with potential off-label use for MDD. 4) Novel rapid-acting antidepressants like Zuranolone (GABA-A receptor modulator) - in late-stage clinical trials for MDD.

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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 below

Exclusion 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 57 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 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 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

Pollakiuria

Dry Skin

Dry Mouth

Insomnia

Tinnitus

Vission Blurred

Constipation

Dysuria

Nausea

Fatigue

Coordination Abnormal

Disturbance in Attention

Dizziness postural

Non-cardiac chest pain

Sinus congestion

Irritability

Malaise

Hyperhidrosis

Mood altered

Initial insomnia

Urinary track infeciton

Gastrointestinal disorder

Syncope

Tendon rupture

Viral infection

Chest pain

Costochondritis

Herpes Zoster

Back Pain

Restlessness

Libido decreased

Blepharitis

Panic attack

Chest discomfort

Anal pruritus

Arthralgia

Hypersomnia

Asthenia

Muscle twitching

Nasopharyngitis

Self-injurious ideation

100%

80%

60%

40%

20%

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.

0 / 6Eligibility criteria met

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.