Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder (MDD)

In brief

The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).

Key facts

Study ID

NCT06836063

Run by

Suven Life Sciences Limited

People needed

214

Starts

2025-07-15

Expected to finish

2026-02-23

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Woodland International Research Group LLC — Little Rock, Arkansas, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• ProScience Research Group — Culver City, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• ATP Clinical Research — Orange, California, United States
• Collaborative Neuroscience Research — Torrance, California, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Premier Clinical Research Institute, Inc — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Panhandle Research and Medical Clinic LLC — Pensacola, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• CenExcel iResearch LLC — Decatur, Georgia, United States
• CenExcel iResearch LLC — Savannah, Georgia, United States
• Chicago Research Center Inc. — Chicago, Illinois, United States
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Midwest Research Group — Saint Charles, Missouri, United States
• Redbird Research, LLC — Las Vegas, Nevada, United States
• Vector Clinical Trials — Las Vegas, Nevada, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Hassman Research Institue — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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