Evaluation of NBI-1065845 as Adjunctive Therapy for Maintenance of Effect in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Study
- Trial ID
- 2025-520541-72-00
- Protocol
- NBI-1065845-MDD3027
- Sponsor
- Neurocrine Biosciences Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of the study titled "MK-4318 CIDF Target Engagement Study" is not explicitly stated. However, the study is associated with the medical condition of **pain**, suggesting a focus on evaluating the efficacy or mechanism of action of MK-4318 in relation to pain management or relief. Understanding the engagement of MK-4318 with its target could provide insights into its potential therapeutic benefits or inform future clinical applications in pain treatment. No secondary objectives are provided in the available data.
Participants
The clinical trial focuses on **pain** management and involves a study population consisting exclusively of male participants. The age range of the participants is categorized under code "3," which typically represents adults, although specific age details are not provided. The trial does not include a vulnerable population, and the general health status of the participants is not specified. The total number of participants is not disclosed, as the sponsor has not provided this information. Selection criteria, including any lifestyle considerations such as diet or physical activity, are not detailed in the available data. The trial does not specify any principal inclusion or exclusion criteria, and the main objective of the study is not mentioned.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy of a new intervention for **pain** management. This study is a Phase 3 trial, which is typically conducted to confirm the effectiveness of a treatment, monitor side effects, and collect information that will allow the treatment to be used safely. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group or the control group, and neither the participants nor the researchers will know which group the participants are in, thus minimizing bias.
The trial is expected to commence recruitment on April 15, 2024, and is estimated to conclude by July 19, 2024. The duration of participant involvement will vary depending on the specific protocol of the study, but it is anticipated to span several months. The study will include a series of visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This will be followed by regular follow-up visits to monitor the participants' response to the treatment and to collect data on any adverse events. The end-of-study visit will be conducted to gather final data and ensure the well-being of the participants.
Participants may be withdrawn from the study early if they experience significant adverse effects, if they do not adhere to the study protocol, or if they choose to withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and rights of all participants. The study aims to provide valuable insights into the management of both acute and chronic pain, contributing to the development of more effective treatment strategies.
Treatment
The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.
In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on April 15, 2024, with an estimated end date of July 19, 2024. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to the standard protocols for Phase 3 studies, ensuring rigorous assessment of the treatment's effectiveness. The trial's design and execution will follow established clinical guidelines to ensure the reliability and validity of the efficacy data collected.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 1.Completed informed consent.
- 2.≥18 years of age at the time of signing the informed consent.
- The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. The MDD diagnosis must be confirmed using the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
- The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.
- Subject must have an Inadequate Response (IR) to oral antidepressant treatments that were administered as adequate courses (dose, duration, adherence) in the current episode of depression, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
- 7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- 13.Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Exclusion Criteria
- 1.A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that has been evident outside of depressive episodes or that may interfere with participation in the study; or a diagnosis of neurodegenerative disorder (including but not limited to dementia), eating disorder (except binge eating disorder), schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, intellectual disability, or mental disorder due to a general medical condition as defined in DSM-5.
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- 6.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
- 9.Pregnant (ie, positive pregnancy test at screening or baseline), lactating, or plans to become pregnant during the study.
- 10.An unstable medical condition or unstable chronic disease (including history of neurological [including cognitive impairment, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) within 3 months before Day 1, or malignancy within 6 months before Day 1.
- 11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.
- 12.History of epilepsy, seizures, or convulsions.
- 13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma.
- 20.Any reason that makes the subject unsuitable for participation in this study (eg, subject is homeless, known to have difficulty complying with treatment or medical procedures, known to provide inaccurate medical information, or known to attempt participation in clinical trials inappropriately) per the investigator, Medical Monitor, and/or Sponsor.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Recruiting | 01 Nov 2025 | 45 |
 Estonia | Recruiting | 01 Nov 2025 | 28 |
 Italy | Recruiting | 01 Nov 2025 | 25 |
 Poland | Recruiting | 01 Nov 2025 | 33 |
 Spain | Recruiting | 01 Nov 2025 | 27 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
NBI-1065845 | Test | TABLET | ORAL | 00 | 33 | PRD9147748 |
Identical to NBI-1065845 tablets without active drug | Placebo | N/A | — | — | — | N/A |