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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Children’s Health Medical Center EOOD	Sofia	Bulgaria
Ambulatory-Group Practice For Specialized Psychiatric Help Datamed Ltd.	Pleven	Bulgaria
Gyncentrum Sp. z o.o.	Katowice	Poland
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska	Torun	Poland

Other Sites

Site Name	City	Country
Praglandia s.r.o.	Prague	Czechia
INEP medical s.r.o.	Prague	Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Medical Center Mentalcare Ltd.	Plovdiv	Bulgaria
Clintrial s.r.o.	Prague	Czechia
A-Shine s.r.o.	Plzen	Czechia
Multiprofile Hospital For Active Treatment – Targovishte AD	Targovishte	Bulgaria
Forbeli s.r.o.	Prague	Czechia
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda	Suchy Las	Poland
Clinic BBP Bożena Pawełczyk	Katowice	Poland
Mjonfgfygee sykjya	Poruba	Czechia
Mojwcw sradza	Brno	Czechia
Crwprm Fdh Mljfmt Hxajhq Vsapfx Eykv	Vratsa	Bulgaria
Mqzpvm Hoxakq Cmrbrx Ssxot Ecyz	Sofia	Bulgaria
Pwsvfffzi Cghhpjg Phgufkrurjclqkv	Bialystok	Poland
Ukoetohhpwrfwp Czfcwxj Kngovfwxq	Gdansk	Poland
Okpmjqt Buvgi Klrbyjoqfuk Cqmwyrbkr Smbt Ete Gthsjkaxumaok Msswdrivlg Tlltjgs	Bydgoszcz	Poland
Pgnmswdy Gpohldaz Ltxthtgsb „bwbshkovmzi Alia Aopegsnul Twbufuf	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	17.05.2025
Czechia	Recruiting	17.05.2025
Poland	Recruiting	17.05.2025

Trial locations

Investigated drugs:

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

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.

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 ID:

2024-520333-68-00

Protocol code:

VP-VHX-896-3201

NCT ID:

NCT06830044

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?