Ziegzdriu K. – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 28 Aug 2026 04:34:33 +0000 en-US hourly 1 https://wordpress.org/?v=7.1 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Ziegzdriu K. – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Safety and Tolerability Study of NBI-1065845 as Additional Treatment for Adults with Major Depressive Disorder https://clinicaltrials.eu/trial/safety-and-tolerability-study-of-nbi-1065845-as-additional-treatment-for-adults-with-major-depressive-disorder/ Mon, 03 Aug 2026 10:39:44 +0000 https://clinicaltrials.eu/trial/safety-and-tolerability-study-of-nbi-1065845-as-additional-treatment-for-adults-with-major-depressive-disorder/ This study focuses on people with 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 NBI-1065845 when used together with existing antidepressant treatments in adults who have not responded well enough to current antidepressant medications alone.

The purpose of this research is to assess how safe and well-tolerated NBI-1065845 is when taken as an additional treatment alongside regular antidepressant medication. The study medication comes in the form of oral tablets that participants take along with their current antidepressant treatment.

This is a long-term study that lasts for approximately 52 weeks (one year). During this time, all participants receive the study medication NBI-1065845 while continuing their current antidepressant treatment at the same dose they were taking before joining the study. The study team monitors participants’ health and any side effects that may occur throughout the treatment period.

]]> Assessment of NBI-1065845 as an Additional Treatment for Adults with Major Depressive Disorder https://clinicaltrials.eu/trial/assessment-of-nbi-1065845-as-an-additional-treatment-for-adults-with-major-depressive-disorder/ Mon, 03 Aug 2026 10:38:45 +0000 https://clinicaltrials.eu/trial/assessment-of-nbi-1065845-as-an-additional-treatment-for-adults-with-major-depressive-disorder/ This study focuses on Major Depressive Disorder (MDD), a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The research evaluates the medication NBI-1065845 when added to existing antidepressant treatment for adults whose depression has not adequately responded to their current medication.

The purpose of this study is to determine if NBI-1065845 is effective and safe compared to placebo when used as an additional treatment for people with moderate to severe depression. Participants in this study will continue taking their regular antidepressant medication while also receiving either the study drug or placebo.

The study will monitor changes in depression symptoms over an 8-week period. Participants will need to attend regular appointments for evaluations of their depression symptoms using standardized rating scales that measure the severity of depression and how it affects daily functioning.

]]> Study on the Effects of BH-200 (Nelivaptan) for Patients with Major Depressive Disorder https://clinicaltrials.eu/trial/study-on-the-effects-of-bh-200-nelivaptan-for-patients-with-major-depressive-disorder/ Mon, 03 Aug 2026 10:28:21 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-bh-200-nelivaptan-for-patients-with-major-depressive-disorder/ 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.

]]> Study on Long-Term Safety of Iclepertin for Patients with Schizophrenia Who Completed Previous Trials https://clinicaltrials.eu/trial/study-on-long-term-safety-of-iclepertin-for-patients-with-schizophrenia-who-completed-previous-trials/ Mon, 03 Aug 2026 10:18:56 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-iclepertin-for-patients-with-schizophrenia-who-completed-previous-trials/ This clinical trial is focused on studying the long-term safety of a medication called Iclepertin in individuals with schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. The trial involves participants who have previously completed a 26-week treatment period with Iclepertin or a matching placebo in earlier studies. The medication is taken as a film-coated tablet once daily.

The purpose of this study is to gather additional safety information about Iclepertin in patients who have cognitive impairment due to schizophrenia. Cognitive impairment refers to difficulties with thinking, memory, and concentration, which can be a part of schizophrenia. Participants in this study will continue to take Iclepertin daily for up to 12 months. The study will monitor the occurrence of any new or worsening side effects, known as treatment emergent adverse events, throughout the trial.

In addition to monitoring side effects, the study will also assess changes in the severity of the participants’ condition using a measure called the Clinical Global Impressions – Severity (CGI-S) scale. This scale helps to evaluate how severe the symptoms are at the start of the study compared to the end. The study aims to provide valuable information on the long-term safety of Iclepertin for people living with schizophrenia.

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