A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open Label Long-term Extension Treatment With Aticaprant

Study of Aticaprant for Major Depressive Disorder

NCT: NCT06514742 · Status: TERMINATED · Phase: Phase 3 · Sponsor: Janssen Research & Development, LLC · Started: 2024-06-26 · Est. Completion: 2025-04-24

Plain English Summary

A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant is a Phase 3 clinical trial sponsored by Janssen Research & Development, LLC studying Depressive Disorder, Major, Anhedonia. Tests how well aticaprant works as an add-on treatment to current antidepressants for adults with major depressive disorder and moderate-to-severe anhedonia who haven't responded well to previous treatments. For adults aged 18 and older with major depressive disorder and anhedonia who have tried at least one antidepressant without success. Participation involves taking either aticaprant or a placebo tablet daily for up to 43 days, followed by an optional open-label phase for up to 31 weeks. Alternative treatments include other antidepressants or psychotherapy. The trial aims to enroll 101 participants.

Official Summary

The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible participants must be medically stable and have a diagnosis of major depressive disorder with anhedonia. Participants must have tried at least one antidepressant and not responded well to it. Age range is 18 and older. Good overall health and no history of severe substance use disorders. This trial is studying Depressive Disorder, Major, Anhedonia, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the improvement in depressive symptoms using the Montgomery-Asberg Depression Rating Scale. The specific primary outcome measures are: Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a treatment gap for individuals with major depressive disorder who have not responded to previous antidepressant treatments. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Depressive Disorder, Major, Anhedonia, where improved treatment options are needed.

Investor Insight

The market for new treatments for major depressive disorder is large, with significant unmet needs, making this trial potentially valuable for investors. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have tried at least one antidepressant and haven't responded well to it. Participation involves taking a tablet daily for up to 43 days, followed by an optional open-label phase for up to 31 weeks. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: RANDOMIZED
  • Model: PARALLEL
  • Masking: DOUBLE
  • Enrollment: 101 participants

Interventions

  • DRUG: Aticaprant — Aticaprant tablet will be administered orally.
  • OTHER: Placebo — Placebo tablet will be administered orally.

Primary Outcomes

  • Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43)

Secondary Outcomes

  • Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score (Baseline to Day 43)
  • Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score (Baseline to Day 43)
  • Change From Baseline Over Time in MADRS Total Score (For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31)
  • Percentage of responders on Depressive Symptoms Scale, Defined as a Greater Than or Equal to (>=) 50 Percent (%) Improvement in MADRS Total Score From Baseline to Day 43 (Baseline to Day 43)
  • Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43 (Day 43)

Full Eligibility Criteria

Inclusion Criteria:

* Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and double blind (DB) baseline
* Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features (DSM-5 296.22, 296.23, 296.32, or 296.33), based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 axis I disorders-clinical trials version (SCID-CT)
* Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to MDE module symptom Item 2) on the SCID-CT at screening
* Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose
* Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI) antidepressants at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, or desvenlafaxine at a stable dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire (MGH ATRQ) for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression

Exclusion Criteria:

* Has had no response (treatment failure) to 2 or more consecutive antidepressant treatments administered at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current episode of depression including the current SSRI/SNRI (that is the one to be continued in the treatment phases) assessed using the MGH ATRQ
* Has one or more of the following diagnoses: (1) a current or prior (lifetime) DSM-5 diagnosis of: (a) a psychotic disorder or MDD with psychotic features, (b) bipolar or related disorders, (c) intellectual disability, (d) autism spectrum disorder, (e) borderline personality disorder, (f) antisocial personality disorder, (g) histrionic personality disorder, (h) narcissistic personality disorders, (i) somatoform disorders; (2) A primary DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of: (a) panic disorder, (b) generalized anxiety disorder, (c) social anxiety disorder, (d) specific phobia; (3) A current (in the past year) DSM-5 diagnosis of: (a) obsessive-compulsive disorder, (b) post-traumatic stress disorder, (c) anorexia nervosa, (d) bulimia nervosa
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
* Has in the current depressive episode had vagal nerve stimulation or deep brain stimulation device in the current episode or has had an inadequate response to an adequate course of intravenous or intranasal ketamine or esketamine (greater than \[\>\] 2 treatments), or electroconvulsive therapy (that is at least 7 treatments)
* Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the columbia suicidality severity rating scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past 6 months prior to the start of the screening phase. Participants reporting suicidal ideation with intent to act or suicidal behavior at DB baseline should be excluded

Trial Locations

  • UAB Huntsville Regional Medical Campus, Huntsville, Alabama, United States
  • IMA Clinical Research PC, Phoenix, Arizona, United States
  • Noble Clinical Research, Tucson, Arizona, United States
  • Advanced Research Center Inc, Anaheim, California, United States
  • CI Trials, Bellflower, California, United States
  • Behavioral Research Specialists LLC, Glendale, California, United States
  • Sun Valley Research Center, Imperial, California, United States
  • ATP Clinical Research, Orange, California, United States
  • Lumos Clinical Research Center LLC, San Jose, California, United States
  • Viking Clinical Research Ltd, Temecula, California, United States
  • ...and 10 more locations

Frequently Asked Questions

What is clinical trial NCT06514742?

NCT06514742 is a Phase 3 INTERVENTIONAL study titled "A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant." It is currently terminated and is sponsored by Janssen Research & Development, LLC. The trial targets enrollment of 101 participants.

What conditions does NCT06514742 study?

This trial investigates treatments for Depressive Disorder, Major, Anhedonia. The primary condition under study is Depressive Disorder, Major.

What treatments are being tested in NCT06514742?

The interventions being studied include: Aticaprant (DRUG), Placebo (OTHER). Aticaprant tablet will be administered orally.

What does Phase 3 mean for NCT06514742?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06514742?

This trial is currently "Terminated." It started on 2024-06-26. The estimated completion date is 2025-04-24.

Who is sponsoring NCT06514742?

NCT06514742 is sponsored by Janssen Research & Development, LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06514742?

The trial aims to enroll 101 participants. The trial status is terminated.

How is NCT06514742 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06514742?

The primary outcome measures are: Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06514742 being conducted?

This trial is being conducted at 20 sites, including Huntsville, Alabama; Phoenix, Arizona; Tucson, Arizona; Anaheim, California and 16 more sites (United States).

Where can I find official information about NCT06514742?

The official record for NCT06514742 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06514742. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06514742 testing in simple terms?

Tests how well aticaprant works as an add-on treatment to current antidepressants for adults with major depressive disorder and moderate-to-severe anhedonia who haven't responded well to previous treatments. For adults aged 18 and older with major depressive disorder and anhedonia who have tried at least one antidepressant without success.

Why is this trial significant?

This trial aims to fill a treatment gap for individuals with major depressive disorder who have not responded to previous antidepressant treatments. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06514742?

Potential side effects include nausea, headache, and dizziness. Participants should report any unusual symptoms to the study team. The study team will monitor for any serious side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06514742?

Ask your doctor if you have tried at least one antidepressant and haven't responded well to it. Participation involves taking a tablet daily for up to 43 days, followed by an optional open-label phase for up to 31 weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06514742 signal from an investment perspective?

The market for new treatments for major depressive disorder is large, with significant unmet needs, making this trial potentially valuable for investors. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves taking either aticaprant or a placebo tablet daily for up to 43 days, followed by an optional open-label phase for up to 31 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.