Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

Launched by SUVEN LIFE SCIENCES LIMITED · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test a medication called Ropanicant for people suffering from Major Depressive Disorder (MDD). The main goal is to see how effective Ropanicant is at two different doses compared to a placebo, which is a harmless pill that looks like the medication but has no active ingredients. The trial is currently not recruiting participants, but it aims to include adults aged 18 to 75 who have been experiencing a major depressive episode for at least four weeks but no longer than 12 months.

To participate, individuals must meet certain criteria, such as having a specific level of depression severity and being in good overall health. However, those with treatment-resistant depression, meaning they haven’t improved with previous treatments, or those with significant health issues will not be eligible. Participants can expect to be assessed through interviews and questionnaires to measure their depression symptoms throughout the study. This trial is an important step in exploring new treatment options for MDD, and anyone considering participation should discuss it with their healthcare provider for more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
• • Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
• • Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
• • Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
• • Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
• Exclusion Criteria:
• • Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (\<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
• • Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
• • Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
• • Patients with bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG results.