A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia
Study of Aticaprant Plus Antidepressant for Depression Prevention
Plain English Summary
A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure is a Phase 3 clinical trial sponsored by Janssen Research & Development, LLC studying Depressive Disorder, Major, Anhedonia. Tests how well aticaprant works with antidepressants to prevent depression relapse in those with major depressive disorder and anhedonia. For adults with major depressive disorder who have lost interest and pleasure in activities and have responded to treatment. Participation involves taking aticaprant or placebo along with antidepressants, with regular check-ups and assessments. Alternatives include standard antidepressant therapy alone or other depression management strategies. The trial aims to enroll 47 participants.
Official Summary
The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older, medically stable, and diagnosed with major depressive disorder with anhedonia. Excluded if they have not responded to at least two antidepressants, substance use disorders, or suicidal thoughts. No specific age limits, but participants must be medically stable and able to understand the study requirements. Health requirements include stable physical and medical conditions, 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 time to relapse, helping patients understand how well the treatment prevents depression from returning. The specific primary outcome measures are: Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse (From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase)). 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 the gap in treatment options for those with major depressive disorder and anhedonia, offering a new adjunctive therapy. 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 large market for depression treatments and the unique focus on anhedonia make this trial significant, with a competitive landscape and a high approval probability. 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 a stable response to antidepressants and experience loss of interest and pleasure. Participation involves taking a pill daily and attending regular clinic visits for assessments. 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: 47 participants
Interventions
- DRUG: Aticaprant — Aticaprant will be administered orally.
- OTHER: Placebo — Placebo will be administered orally.
Primary Outcomes
- Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse (From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase))
Secondary Outcomes
- Change in Sexual Function (SF) Measured by Changes in Sexual Functioning Questionnaire - Short-Form (CSFQ-14) Total Score From DB Baseline to End of Week 4 of the DB Treatment Maintenance Phase (From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study))
- Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase (From Week 16 (DB baseline) up to 2 years 2 months in the DB phase)
- Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10 (From Week 16 (DB baseline) up to 2 years 2 months in the DB phase)
- Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4) (From Week 16 (DB baseline) up to 2 years 2 months in the DB phase)
- Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time (For open-label (OL) treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in DB phase)
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 OL baseline * Be medically stable based on clinical laboratory tests performed at screening * Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition (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 major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening Exclusion Criteria: * Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) * 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 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 * Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
Trial Locations
- Preferred Research Partners, Little Rock, Arkansas, United States
- Wake Research PRI Encino, Encino, California, United States
- Wr Pri Llc, Newport Beach, California, United States
- ATP Clinical Research, Orange, California, United States
- Myndful Research, Redlands, California, United States
- Artemis Institute for Clinical Research, San Diego, California, United States
- UHC Research, Doral, Florida, United States
- Pharmax Research Clinic Inc, Miami, Florida, United States
- GTL Medical and Research Group, Miami, Florida, United States
- International Research Associates, LLC, Miami, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06635135?
NCT06635135 is a Phase 3 INTERVENTIONAL study titled "A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure." It is currently terminated and is sponsored by Janssen Research & Development, LLC. The trial targets enrollment of 47 participants.
What conditions does NCT06635135 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 NCT06635135?
The interventions being studied include: Aticaprant (DRUG), Placebo (OTHER). Aticaprant will be administered orally.
What does Phase 3 mean for NCT06635135?
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 NCT06635135?
This trial is currently "Terminated." It started on 2024-09-19. The estimated completion date is 2025-04-25.
Who is sponsoring NCT06635135?
NCT06635135 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 NCT06635135?
The trial aims to enroll 47 participants. The trial status is terminated.
How is NCT06635135 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 NCT06635135?
The primary outcome measures are: Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse (From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06635135 being conducted?
This trial is being conducted at 20 sites, including Little Rock, Arkansas; Encino, California; Newport Beach, California; Orange, California and 16 more sites (United States).
Where can I find official information about NCT06635135?
The official record for NCT06635135 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06635135. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06635135 testing in simple terms?
Tests how well aticaprant works with antidepressants to prevent depression relapse in those with major depressive disorder and anhedonia. For adults with major depressive disorder who have lost interest and pleasure in activities and have responded to treatment.
Why is this trial significant?
This trial aims to fill the gap in treatment options for those with major depressive disorder and anhedonia, offering a new adjunctive therapy. 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 NCT06635135?
Potential side effects include nausea, headache, and dizziness, which are common with antidepressants. Monitor for any unusual symptoms and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06635135?
Ask your doctor if you have a stable response to antidepressants and experience loss of interest and pleasure. Participation involves taking a pill daily and attending regular clinic visits for assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06635135 signal from an investment perspective?
The large market for depression treatments and the unique focus on anhedonia make this trial significant, with a competitive landscape and a high approval probability. 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 aticaprant or placebo along with antidepressants, with regular check-ups and assessments. 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.
Related Conditions
More Depressive Disorder, Major Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.