Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients
NCT ID: NCT06836063
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
195 participants
INTERVENTIONAL
2025-07-15
2026-02-28
Brief Summary
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Detailed Description
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This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ropanicant Dose Level 1
Ropanicant
Tablet dosage form, twice a day
Ropanicant Dose Level 2
Ropanicant
Tablet dosage form, twice a day
Placebo
Placebo
Matching placebo tablets, twice a day
Interventions
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Ropanicant
Tablet dosage form, twice a day
Placebo
Matching placebo tablets, twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Suven Life Sciences Limited
INDUSTRY
Responsible Party
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Locations
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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
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Eximia Research-NC, LLC
Raleigh, North Carolina, United States
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
North Texas Clinical Trials, LLC
Fort Worth, Texas, United States
Memorial Hermann Village
Houston, Texas, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Other Identifiers
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CTP2S2911A4B2
Identifier Type: -
Identifier Source: org_study_id
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