What side effects are associated with this type of intervention?

Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) are commonly used to treat Major Depressive Disorder (MDD). Common side effects of SSRIs include nausea, headache, sexual dysfunction, insomnia, and weight gain. SNRIs share similar side effects, such as nausea, dry mouth, dizziness, excessive sweating, and increased blood pressure. Both classes of medications can also lower the seizure threshold and should be used cautiously in patients with central nervous system diseases.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Major Depressive Disorder (MDD), particularly as adjunctive therapies to selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). Notable examples include aripiprazole and quetiapine, which are often used to augment the effects of SSRIs or SNRIs in patients who do not respond adequately to antidepressant monotherapy. These medications help enhance the therapeutic effects and improve symptom control in treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to Aticaprant for adjunctive therapy in MDD include: <ol> <li>Aripiprazole: Shown to be effective in augmenting SSRIs/SNRIs with a favorable side effect profile.</li> <li></li> </ol> Brexpiprazole: Similar to Aripiprazole but with potentially fewer side effects like akathisia. 3. Quetiapine: Another second-generation antipsychotic with evidence supporting its use in treatment-resistant depression. 4. Cariprazine: A newer antipsychotic with emerging evidence for its efficacy in MDD. 5. Varenicline: Primarily used for smoking cessation but has shown promise in patients with severe mental illness, including MDD.

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Aticaprant for Depression (VENTURA-LT 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

BMI 18-40

Must not have

You have been diagnosed with Psychosis

You have been diagnosed with Substance Use Disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 54

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if adding aticaprant to current antidepressants is safe and well-tolerated in people with major depressive disorder. The goal is to see if it can help improve their treatment.

Who is the study for?

This trial is for adults with Major Depressive Disorder who haven't had enough improvement after trying 1-3 antidepressants. They must have a certain score on a depression rating scale and meet specific diagnostic criteria without psychotic features. Employees of the study or those with allergies to aticaprant can't participate.

What is being tested?

The trial tests Aticaprant's long-term safety and effectiveness when added to current SSRI or SNRI treatments in patients with depression. It aims to see if this combination helps people who didn't respond well to previous medications.

What are the potential side effects?

While not specified here, potential side effects may include typical reactions seen with antidepressants such as nausea, headaches, sleep disturbances, sexual dysfunction, and possibly unique risks associated with Aticaprant.

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 ~ week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 54 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Abnormal Body Mass Index (BMI)

Number of Participants with Abnormal Body Weight

Number of Participants with Abnormalities in Clinical Laboratory parameters

+7 more

Secondary study objectives

Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time

Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time

Mental Depression

+3 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

Viral infection

Mood altered

Costochondritis

Initial insomnia

Urinary track infeciton

Gastrointestinal disorder

Syncope

Tendon rupture

Chest pain

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aticaprant 10 mgExperimental Treatment1 Intervention

Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.

0 / 11Eligibility 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

The most common treatments for Major Depressive Disorder (MDD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). SSRIs work by increasing serotonin levels in the brain, while SNRIs increase both serotonin and norepinephrine levels. These neurotransmitters play key roles in mood regulation. Adjunctive therapies like Aticaprant are being studied to further enhance the efficacy of SSRIs or SNRIs by targeting additional pathways involved in mood regulation. Understanding these mechanisms is crucial for MDD patients as it allows for more personalized and effective treatment strategies, potentially leading to better management of depressive symptoms.