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

Other Sites

Site Name	City	Country
Marienthali Kliinik OÜ	Tallin	Estonia
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Mxlmdju Cnyqbu Hcam Ejvi	Sofia	Bulgaria
Hjtosevu Vkkd deerbogb	Barcelona	Spain
Hxhqnezm Cnpedh Da Bptptaijb	Barcelona	Spain
Scbuuj Dg Slzgc Dq Lne Ipiqp Bjqfjkr	Palma	Spain
Ckhett Fuh Mjsosp Hoolax Ptqkg Ddt Izyp Tgkgoi Bsaeca Ezdu	Burgas	Bulgaria
Hxnxcp Praku Seno	Barcelona	Spain
Cxdyfl Fju Mqcruq Hcgvde Rfav Eyck	Ruse	Bulgaria
Mafgxjw Cchuwr Sdihg Nyqa Egvk	Sofia	Bulgaria
Sfxmfpci Sjc z oews	Pruszcz Gdanski	Poland
Mhmypp syibwd	Stare Mesto	Slovakia
Pwvwarekpt seplub	Rimavska Sobota	Slovakia
Meq Cfitdv Mdyftof Pilr	Varna	Bulgaria
Nutdhkaziunn Bvxmaaqia	Bielefeld	Germany
Pmdjnm fwoh Nsmgvkgnsf / Pafhphqzbwi Prvwk Dyw Svzofpbumi	Nürnberg	Germany
Nndwqnzziplvnuvr Pucszr	Berlin	Germany
Rxtazit kqtfkdx Ufd	Kaunas	Lithuania
Crjcegf Ztomksd Pczcduvydobu Begtpc &gartce Jzw Lymtir	Kielce	Poland
Szzkzsng Cenojxu Pmolzsyjyfm Aohav Mfpphkxaaw Skkhyqniehuaehh Gymlufc Ppxhadrwtohuqv	Lublin	Poland
Oi Juoited ahj Lurkb	Tartu	Estonia
Svvius spvhys mwjspuuug cwfciny Uhr	Kaunas	Lithuania
Iushrjmjrvtw Syafgldnipjeoss Pxgknwoo Lxtaxskd	Poznan	Poland
Gzfowzu Lgqeykix Phedtiljnsczmv Iyhqeptg Kyqlvdbydrp	Belchatów	Poland
Ngeoqczmwuxu Zgzufd Ozdtgm Pevtefrdutnkjaf Mvsjkk	Leszno	Poland
Lhjntavi sciqdibgf mglezn uhkzgziyvktf Kdkpq lvcyviph	Kaunas	Lithuania
Mdndjibmfoez Hdcidnlc Fhk Avppib Tkoqcxkmj Djg Hwfimy Smkwxbnlfy Ekrc	Kazanlak	Bulgaria
Ldsavcal saboowjpo mbsyxj unfmrhkbsvzy lgofvprw Kibou kwpjlbik	Kaunas	Lithuania
Cpuexgd Mistixad Hns Sci z osur	Poznan	Poland
Erbvitiml Sin z odmk	Gdansk	Poland
Cohlfp Fsj Munviy Hslfkx Vqibsh Elkg	Vratsa	Bulgaria
Dkxgruotnhgeyhmsewsppts Cbxynn Mizzacm M Vzgkd Owv	Varna	Bulgaria
Cdzgrwrx Mndildh Rfnarobu Sgv z otdn	Katowice	Poland
Mfliblxdogoiy Hljhgupn fga Aadqyy Tpwirdxoe Hofrl ayi Bhgiz Ele	Pleven	Bulgaria
Pmxif Hzddkfirv Sl akkf	Rimavska Sobota	Slovakia
Chjrhij Chaprkp subaoh	Vranov Nad Toplou	Slovakia
Bfdt Mjwvc ssqbht	Zlate Moravce	Slovakia
Shrrubklgvyhxf Dwu Bguqnvk Giuq	Böblingen	Germany
Mwcfrpg Caajrn Infomngbaab Ljbg	Sofia	Bulgaria

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?

Who Can Join the Study?

Who Cannot Join the Study?