Study on the Effects of BH-200 (Nelivaptan) for Patients with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Nelivaptan on individuals with Major Depressive Disorder (MDD). MDD is a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The study aims to evaluate how effective and tolerable a fixed dose of Nelivaptan, also known by its code name BH-200, is in improving symptoms of depression in patients who have a specific genetic profile related to the V1b receptor.

The trial will last for 14 weeks, with an 8-week period where participants will receive either Nelivaptan or a placebo. Participants will take the medication in capsule form, twice a day. Throughout the study, the participants’ depressive symptoms will be monitored and assessed using various scales and questionnaires to determine any changes in their condition. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The primary goal of this study is to see if Nelivaptan can effectively reduce depressive symptoms compared to a placebo. Participants will be regularly evaluated to track their progress and any side effects they may experience. This research could provide valuable insights into new treatment options for those suffering from Major Depressive Disorder.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, body mass index, and diagnosis of major depressive disorder.

Participants must provide written informed consent and agree to stop any current antidepressant or prohibited psychotropic medication before the study begins.

2 baseline assessment

A baseline assessment is conducted to evaluate the initial condition using various scales, such as the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS).

This assessment helps establish a starting point for measuring changes throughout the study.

3 treatment period

The treatment period lasts for 8 weeks. During this time, participants receive either a fixed dose of BH-200 (250 mg twice daily) or a placebo.

The medication is administered orally in capsule form.

4 regular assessments

Throughout the treatment period, regular assessments are conducted to monitor changes in depressive symptoms and overall health.

These assessments include various scales and questionnaires to evaluate mood, anxiety, and daily functioning.

5 follow-up visit

A follow-up visit occurs after the 8-week treatment period to assess the participant’s condition and any changes in symptoms.

This visit includes a final evaluation using the same scales and questionnaires as during the treatment period.

6 end of study

The study concludes with a comprehensive review of all collected data to determine the efficacy and tolerability of the treatment.

Participants are informed of the study’s findings and any implications for their ongoing care.

Who Can Join the Study?

Must be a male or female patient.
The current episode of depression should not have lasted longer than 12 months before the screening.
Symptoms of depression must have been present for at least 2 weeks before the screening.
Must be willing to stop current antidepressant or other prohibited medications, except for certain sleeping and anti-anxiety medications, at least 7 days before the study starts.
If undergoing psychotherapy, it must have been ongoing for at least 6 weeks before screening and cannot be stopped or changed until 8 weeks after starting treatment.
If participating in a physical activity program, it must have been ongoing for at least 6 weeks before screening and cannot be stopped or changed until 8 weeks after starting treatment.
Ongoing hormone therapy for post-menopausal women, insulin for diabetes, and treatment for thyroid disorders are allowed if these conditions are well controlled.
Women who can have children must use highly effective birth control methods from the time of consent until 28 days after the last dose of the study drug.
Male patients must use effective birth control methods or practice abstinence during the study and for 28 days after the last dose of the study drug.
Must be between 18 and 75 years old at the time of consent. In Serbia, the age range is 18 to 65 years.
Body mass index (BMI) must be between 18 and 35 kg/m².
Must be an outpatient, meaning not admitted to a hospital.
Must be able to understand the study’s purpose and risks and provide signed consent.
In Bulgaria, a caregiver must be available for the study duration, and the caregiver must also provide consent.
Must have a primary diagnosis of Major Depressive Disorder (MDD), which can be moderate or severe, with or without psychotic features, confirmed by specific diagnostic tools.
Can have certain other conditions like anxiety disorders or obsessive-compulsive disorder, as long as MDD is the main diagnosis and these conditions do not interfere with the study.
Must have a MADRS score of 20 or higher at screening and baseline. The MADRS score is a measure used to assess the severity of depression.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication or similar medications.
Patients who are currently participating in another clinical trial.
Patients with a diagnosis of another major psychiatric disorder, such as schizophrenia or bipolar disorder.
Patients with a serious medical condition that could interfere with the study, such as uncontrolled diabetes or heart disease.
Patients who are pregnant or breastfeeding.
Patients who have a substance abuse problem, meaning they use drugs or alcohol in a way that could affect their health or the study results.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who are unable to follow the study procedures or take the study medication as directed.
Patients who have been hospitalized for depression in the past 6 months.
Patients who are at risk of harming themselves or others.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Pharmakologisches Studienzentrum Chemnitz GmbH	Chemnitz	Germany
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.	Plovdiv	Bulgaria
University Hospital Jena KöR	Jena	Germany
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen	Siegen	Germany

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
E4r&D Sp. z o.o.	Gdansk	Poland
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Clinical Medical Research Sp. z o.o.	Katowice	Poland
Penta Hospitals SK a.s.	Rimavska Sobota	Slovakia
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Marienthali Kliinik OÜ	Tallin	Estonia
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Bona Medic s.r.o.	Zlate Moravce	Slovakia
Crystal Comfort s.r.o.	Vranov Nad Toplou	Slovakia
Lietuvos sveikatos mokslu universiteto Kauno ligonine	Kaunas	Lithuania
Saules seimos medicinos centras UAB	Kaunas	Lithuania
Hospital Clinic De Barcelona	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD	Kazanlak	Bulgaria
Clpwiv Fev Mndoxq Hbwxyd Pdtim Dmf Ijlv Tdfyxx Bxzhud Enki	Burgas	Bulgaria
Msw Cxhenl Mdlgbhi Pnjs	Varna	Bulgaria
Ctkois Fts Mgnjsz Hcqwam Rklq Eavp	Ruse	Bulgaria
Nsrazbfaikzp Bgvtfrxjx	Bielefeld	Germany
Phmftm fnmc Nwsartshor / Pongbfbutff Pfjfr Dao Sbvrmjvegk	Nürnberg	Germany
Nlrzbwmhnlmqweai Pxcuwg	Berlin	Germany
Riuyccu kcrxmju Upk	Kaunas	Lithuania
Hdfcfm Pgwms Suis	Barcelona	Spain
Chlgbfz Zeawhpr Pynvkrgjyvef Bfkxfd &zsuzth Jkz Lvzwyt	Kielce	Poland
Sxnshbvo Spe z osxd	Pruszcz Gdanski	Poland
Sgnqrnum Cglbgpb Puiyjenvjul Ahnri Mtcytwqazc Shxemxwczjsogae Gfrqqut Psretcrliacefr	Lublin	Poland
Mjkzel smyhkk	Stare Mesto	Slovakia
Pnleyodpal siczwv	Rimavska Sobota	Slovakia
Oa Jhvndpe apw Lpert	Tartu	Estonia
Czuccw Fja Mecgar Hakuan Vqewgu Eyle	Vratsa	Bulgaria
Ggipnap Lrythjgs Phwckomjyggfjs Ikhjclje Kyuavkutbis	Belchatów	Poland
Nwigvjjvvsms Zwsdlc Obusag Pxafidazjkcmkbc Mxcbpz	Leszno	Poland
Iyadnzkioget Sohderipvbxmvse Ppiigzid Lpumuzux	Poznan	Poland
Hylmqbjg Vinl dcmhwarn	Barcelona	Spain
Swzkvvyyptlotf Dgz Bxsiaqa Goof	Böblingen	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	26.05.2023
Estonia	Not recruiting	26.05.2023
Germany	Not recruiting	26.05.2023
Lithuania	Not recruiting	26.05.2023
Poland	Not recruiting	26.05.2023
Slovakia	Not recruiting	26.05.2023
Spain	Not recruiting	26.05.2023

Trial locations

Investigated drugs:

Nelivaptan

BH-200 is a medication being studied for its potential to improve symptoms in patients with Major Depressive Disorder (MDD). The trial aims to evaluate how effective and tolerable this medication is when taken by outpatients. The study focuses on patients with a specific genetic profile, referred to as V1b-high, to see if this medication can help reduce their depressive symptoms.

Investigated diseases:

Major depression

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder often involves changes in sleep patterns, appetite, energy level, concentration, daily behavior, or self-esteem. Symptoms must last at least two weeks for a diagnosis to be made. The severity and duration of symptoms can vary, and they may occur in episodes throughout a person’s life.

Trial ID:

2024-513104-34-00

Protocol code:

BH-200-03

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of BH-200 (Nelivaptan) for Patients with Major Depressive Disorder

What is this study about?

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