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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Major Depressive Disorder (MDD), a serious mental health condition characterized by persistent feelings of sadness and loss of interest in daily activities. The research evaluates a new medication called milsaperidone (also known as VHX-896) when used together with existing antidepressant therapy in people whose depression has not adequately improved with current treatment.

The study tests whether taking milsaperidone tablets along with a person's current antidepressant medication helps improve depression symptoms better than taking a placebo with the antidepressant. The medication or placebo will be given as oral tablets, with participants receiving treatment for 6 weeks.

This is a double-blind study where participants will continue their current antidepressant medication while also receiving either milsaperidone or placebo tablets. The main goal is to determine if adding milsaperidone to existing antidepressant treatment helps reduce depression symptoms in people who haven't responded well enough to their current medication alone.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation begins with an evaluation to confirm the diagnosis of Major Depressive Disorder (MDD)

    A healthcare professional will conduct interviews and review your medical history

    You will complete several questionnaires to assess your depression symptoms, including the Montgomery-Asberg Depression Rating Scale (MADRS)

  2. Step 2

    Medication verification

    Your current antidepressant treatment will be reviewed to confirm you have been taking it for at least 6 weeks

    The medication must be one of the following: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, levomilnacipran, milnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either milsaperidone tablets or placebo tablets

    The placebo tablets look identical to the milsaperidone tablets

    You will continue taking your current antidepressant medication throughout the study

  4. Step 4

    Treatment period

    The study treatment period lasts for 6 weeks

    You will take the study medication orally as prescribed

    Regular assessments will measure changes in your depression symptoms

    Your progress will be monitored using the Montgomery-Asberg Depression Rating Scale (MADRS)

  5. Step 5

    Final evaluation

    At the end of 6 weeks, a final assessment will measure changes in your depression symptoms

    The effectiveness of the treatment will be evaluated by comparing your initial and final MADRS scores

Who can join the trial?

18 criteria

  • Patient must be diagnosed with Major Depressive Disorder (MDD) confirmed by a clinical interview and medical records review
  • Current episode of depression must have started between 8 weeks and 24 months before screening
  • Patient must score 24 or higher on the Montgomery-Asberg Depression Rating Scale (a tool that measures depression severity) during screening and baseline visits
  • Patient must have a score of 4 or higher on the Clinical Global Impression Scale (a measure of illness severity) during screening and baseline visits
  • Patient must score 14 or higher on the Quick Inventory of Depressive Symptoms self-report questionnaire during screening and baseline visits
  • Patient must be currently taking one of these antidepressants for at least 6 weeks:
    • bupropion
    • citalopram
    • duloxetine
    • escitalopram
    • fluoxetine
    • paroxetine
    • sertraline
    • venlafaxine
    • desvenlafaxine
    • vilazodone
    • vortioxetine
    • Patient must show inadequate response (less than 50% improvement) to their current antidepressant treatment
    • Both men and women may participate in the study

Who cannot join the trial?

14 criteria

  • Current diagnosis of other psychiatric disorders besides Major Depressive Disorder (MDD)
  • History of not responding to at least two different antidepressant treatments
  • Current use of medications that could interact with the study drug milsaperidone
  • Pregnant or breastfeeding women
  • History of substance abuse within the past 6 months
  • Serious medical conditions that could affect study participation
  • Current suicidal thoughts or behavior
  • Participation in other clinical trials within the past 30 days
  • Known allergies or sensitivity to milsaperidone or similar medications
  • Significant changes in antidepressant medication within the past 4 weeks
  • History of seizures or other neurological disorders
  • Abnormal laboratory test results that could indicate health issues
  • Unable to comply with study visits and procedures
  • History of severe adverse reactions to psychiatric medications
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Investigated drugs

  • Milsaperidone

    is a medication being studied as an add-on treatment for major depressive disorder. It is designed to work together with existing antidepressant medications to potentially improve symptoms of depression in patients who haven't responded adequately to antidepressant treatment alone.

  • Antidepressant therapy

    refers to standard medications used to treat depression. These are the ongoing medications that patients are already taking for their depression. The study aims to see if adding milsaperidone to these existing treatments can help improve depression symptoms better than antidepressant therapy alone.

What is already known about the treatment

Milsaperidone – A novel antipsychotic medication being studied as an adjunctive therapy for Major Depressive Disorder (MDD) in combination with standard antidepressants. The drug belongs to the class of atypical antipsychotics and is administered orally, though specific formulation details are still under clinical investigation. Like other atypical antipsychotics used in depression treatment, milsaperidone likely works by modulating multiple neurotransmitter systems in the brain, including serotonin and dopamine pathways, to help improve depressive symptoms that haven't adequately responded to antidepressant therapy alone. The medication is currently undergoing clinical trials to evaluate its efficacy and safety profile as an add-on treatment for patients with MDD who have not achieved sufficient improvement with standard antidepressant treatment.

Investigated diseases

Major Depressive Disorder - A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and decreased energy lasting for at least two weeks. It affects how a person thinks, feels, and handles daily activities, impacting sleep, appetite, and overall behavior. The condition can involve changes in concentration, decision-making abilities, and self-worth. People with this disorder may experience recurring episodes throughout their lives, with symptoms varying in intensity and duration. The condition affects emotional and physical well-being, potentially causing changes in weight, sleep patterns, and daily routines.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520333-68-00Protocol codeVP-VHX-896-3201Estimated enrolment585 patientsSponsorVanda Pharmaceuticals Netherlands B.V.

sourced from the EU Clinical Trials Register and site verification

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