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(1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL

This article discusses clinical trials investigating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL, also known as milsaperidone. A Phase 3 trial is evaluating this substance as adjunctive therapy for Major Depressive Disorder. The trial aims to assess efficacy and safety when combined with standard antidepressant treatment in 550 patients.

Table of Contents

Overview of the Clinical Trial Program

A comprehensive clinical trial program is currently underway to investigate the potential therapeutic benefits of (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL for patients with Major Depressive Disorder[1]. This investigational substance is being evaluated in an advanced-phase clinical study that aims to provide robust evidence regarding its efficacy and safety profile when used in combination with existing antidepressant medications[1].

The clinical trial program represents a significant effort to address the unmet medical needs of patients with depression who may not achieve adequate symptom relief with standard antidepressant therapy alone[1]. The research is designed as an interventional study, meaning that participants actively receive the investigational treatment, and researchers carefully monitor and measure the outcomes[1].

Understanding (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL

The substance being investigated in this clinical trial is known by its chemical name (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL and is also referred to by its common name milsaperidone[1]. This investigational compound is being studied specifically for its potential to enhance the effectiveness of existing antidepressant treatments[1].

The clinical development of (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL has progressed to Phase 3 testing, indicating that earlier studies have provided sufficient evidence of safety and potential benefit to warrant large-scale evaluation[1]. The substance is being positioned as an adjunctive treatment option, meaning it would be used in addition to, rather than instead of, standard antidepressant medications[1].

Major Depressive Disorder as the Target Condition

Major Depressive Disorder (MDD) is the primary condition being targeted in the clinical trial investigating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL[1]. Major Depressive Disorder is a serious mental health condition characterized by persistent feelings of sadness, hopelessness, loss of interest in previously enjoyed activities, and various physical and cognitive symptoms that significantly impair daily functioning[1].

The trial specifically focuses on patients who are already receiving antidepressant therapy for their Major Depressive Disorder[1]. This target population is particularly important because many individuals with depression do not achieve complete symptom relief with their initial antidepressant treatment alone. The study aims to determine whether adding (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL to existing therapy can provide additional therapeutic benefits for these patients[1].

Phase 3 Trial Design and Objectives

The clinical trial evaluating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL is classified as a Phase 3 study[1]. Phase 3 trials represent one of the final stages of clinical development before a treatment can be considered for regulatory approval and potential availability to patients. These studies typically involve large numbers of participants and are designed to confirm the treatment’s effectiveness, monitor side effects in a broader population, and collect information that allows the treatment to be used safely[1].

The primary objective of this Phase 3 trial is to evaluate the efficacy of milsaperidone as an adjunctive treatment to antidepressant therapy for patients with Major Depressive Disorder[1]. The study also aims to assess the safety profile of the treatment when used in combination with standard antidepressants[1].

The trial design includes several key features:

  • Large-scale enrollment: The study plans to include 550 patients, providing substantial statistical power to detect treatment effects[1]
  • Interventional approach: Participants actively receive the investigational treatment as an addition to their ongoing antidepressant therapy[1]
  • Standardized assessment: The trial uses validated measurement tools to objectively evaluate changes in depression symptoms[1]
  • Defined treatment duration: The primary efficacy assessment occurs at Week 6 of treatment[1]

Adjunctive Therapy Approach

A distinguishing feature of this clinical trial is its focus on adjunctive therapy[1]. In this context, adjunctive therapy means that (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL is being studied as an add-on treatment to existing antidepressant medications, rather than as a standalone treatment or replacement for current therapy[1].

This adjunctive approach is particularly relevant for patients with Major Depressive Disorder who have not achieved adequate symptom control with their current antidepressant medication. The strategy recognizes that while many antidepressants are effective, a significant proportion of patients continue to experience residual symptoms despite treatment. By adding (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL to ongoing antidepressant therapy, researchers hope to enhance treatment outcomes and help more patients achieve meaningful symptom relief[1].

The trial design requires that participants continue their existing antidepressant medication throughout the study period while also receiving the investigational treatment[1]. This allows researchers to specifically evaluate the additional benefit provided by (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL when combined with standard care[1].

Efficacy Measurement and Endpoints

The trial uses the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score as the primary measure of treatment efficacy[1]. The MADRS is a widely recognized and validated clinical assessment tool used by healthcare professionals to evaluate the severity of depression symptoms. It consists of ten items that assess various aspects of depression, including apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts[1].

The primary efficacy endpoint measures the change from baseline to Week 6 in the MADRS Total Score[1]. This means that researchers will:

  • Assess each participant’s depression severity using the MADRS at the beginning of the study (baseline)[1]
  • Repeat the MADRS assessment after 6 weeks of treatment[1]
  • Calculate the difference between these two scores to determine how much improvement occurred[1]
  • Compare the degree of improvement in patients receiving (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL plus antidepressant therapy versus appropriate control groups[1]

The use of a standardized, validated scale like the MADRS ensures that treatment effects are measured objectively and consistently across all study participants and sites[1]. The 6-week timeframe for the primary endpoint is clinically relevant, as it allows sufficient time for potential therapeutic effects to emerge while providing timely information about treatment response[1].

Patient Population and Enrollment

The Phase 3 trial investigating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL plans to enroll approximately 550 patients with Major Depressive Disorder[1]. This substantial enrollment target reflects the Phase 3 nature of the study and is designed to provide adequate statistical power to detect meaningful treatment differences and to characterize the safety profile in a diverse patient population[1].

The target population consists of patients who have been diagnosed with Major Depressive Disorder and are currently receiving antidepressant therapy[1]. This indicates that eligible participants are individuals whose depression is being actively treated but who may benefit from additional therapeutic intervention. The large enrollment number allows the trial to include patients with varied demographic characteristics, disease severity levels, and treatment histories, which helps ensure that the results are broadly applicable to the real-world population of patients with Major Depressive Disorder[1].

Key aspects of the patient population include:

  • Confirmed diagnosis: Participants must have a documented diagnosis of Major Depressive Disorder[1]
  • Current treatment: Patients must be receiving ongoing antidepressant therapy at the time of enrollment[1]
  • Large sample size: The 550-patient enrollment target ensures robust statistical analysis and safety monitoring[1]

Current Trial Status and Timeline

The clinical trial evaluating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL for Major Depressive Disorder currently has an Authorised status[1]. This status indicates that the trial has received the necessary regulatory approvals and authorizations to proceed with patient enrollment and conduct of the study[1].

The authorized status represents an important milestone in the clinical development program, as it confirms that regulatory authorities have reviewed the trial protocol, including the study design, patient population, safety monitoring plans, and other critical elements, and have determined that the study can move forward[1]. This approval process helps ensure that the trial will be conducted according to rigorous scientific and ethical standards that protect participant safety while generating reliable data[1].

The trial is registered with the identifier NCT06830044, which allows patients, healthcare providers, and researchers to access detailed information about the study through clinical trial registries[1]. With its authorized status and Phase 3 designation, this trial represents a crucial step in determining whether (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL can provide meaningful benefits as an adjunctive treatment option for patients with Major Depressive Disorder[1].

Trial ID Phase Condition Studied Status Enrollment Study Type Primary Measure Treatment Duration
NCT06830044 Phase 3 Major Depressive Disorder Authorised 550 patients Interventional MADRS Total Score change 6 weeks

FAQ

  • What is (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL being studied for? This substance, also known as milsaperidone, is being studied as an additional treatment for Major Depressive Disorder. It is being tested as adjunctive therapy, meaning it would be used alongside existing antidepressant medications to potentially improve treatment outcomes.
  • What phase is the clinical trial in? The trial investigating (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL is in Phase 3. This is an advanced stage of clinical testing that evaluates the treatment's effectiveness and safety in a larger patient population before potential approval.
  • How many patients are participating in this trial? The trial is designed to enroll approximately 550 patients with Major Depressive Disorder. This large enrollment number is typical for Phase 3 trials and helps researchers gather sufficient data about the treatment's effectiveness and safety.
  • How is the effectiveness of the treatment measured in this trial? The trial measures effectiveness using the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Researchers compare the change in this score from the beginning of the study to Week 6 to determine if the treatment helps reduce depression symptoms.
  • What does adjunctive therapy mean in this trial? Adjunctive therapy means that (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL is being tested as an add-on treatment. Patients continue taking their regular antidepressant medication while also receiving this investigational treatment to see if the combination works better than antidepressants alone.

Ongoing Clinical Trials on (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL

  • Study of milsaperidone as an additional treatment for adults with Major Depressive Disorder who are already taking antidepressants

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Czechia Poland

Glossary

  • Major Depressive Disorder (MDD): A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and other symptoms that significantly affect daily functioning for at least two weeks.
  • Adjunctive Therapy: An additional treatment used alongside a primary therapy to enhance its effectiveness. In this context, it means adding a new medication to existing antidepressant treatment.
  • Phase 3 Trial: An advanced stage of clinical testing involving large numbers of patients to confirm effectiveness, monitor side effects, and compare the treatment to commonly used therapies.
  • Montgomery-Asberg Depression Rating Scale (MADRS): A standardized questionnaire used by healthcare professionals to measure the severity of depression symptoms, including sadness, tension, sleep problems, and appetite changes.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect under ideal and controlled circumstances, such as in a clinical trial.
  • Baseline: The initial measurements taken at the start of a clinical trial before any treatment is given, used as a reference point to compare changes during the study.
  • Interventional Study: A type of clinical trial where researchers actively give participants a specific treatment or intervention and then measure the outcomes.
  • Enrollment: The process of recruiting and registering participants into a clinical trial, or the total number of participants planned for the study.
  • Antidepressant Therapy: Treatment using medications designed to relieve symptoms of depression by affecting brain chemicals that regulate mood.
  • Milsaperidone: The common name for (1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL, the investigational substance being studied in this trial.

References