Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of Ropanicant in Patients With Major Depressive Disorder

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: Ropanicant; Drug: Placebo

Detailed Description

This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US.

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).

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group LLC
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Culver City, California, United States, 90230
      • Proscience Research Group
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Orange, California, United States, 92866
      • ATP Clinical Research
    • Torrance, California, United States, 90504
      • Collaborative Neuroscience Research
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Pensacola, Florida, United States, 32503
      • Panhandle Research and Medical Clinic LLC
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • CenExcel iResearch LLC
    • Savannah, Georgia, United States, 31405
      • CenExcel iResearch LLC
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center Inc.
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • NeuroBehavioral Medicine Group
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Midwest Research GRoup
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Vector Clinical Trials
    • Las Vegas, Nevada, United States, 89119
      • Redbird Research, LLC
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center For Emotional Fitness
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institue
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research Inc.
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Eximia Research-NC, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Sooner Clinical Research, Inc
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions Inc.
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials, LLC
    • Houston, Texas, United States, 77043
      • Memorial Hermann Village
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo tablets, twice a day
Experimental: Ropanicant Dose Level 1	Drug: Ropanicant; Tablet dosage form, twice a day; Other Names: SUVN-911
Experimental: Ropanicant Dose Level 2	Drug: Ropanicant; Tablet dosage form, twice a day; Other Names: SUVN-911

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6	The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression.	Baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6	The CGI-S will be used to rate the severity of each patient's illness related to depressive symptoms on a 7-point scale, which includes the following gradations: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill.	Baseline to Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6	The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 14 to 56). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.	Baseline to Week 6

Collaborators and Investigators

• Sponsor: Suven Life Sciences Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): February 23, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MDD; SUVN-911; α4β2; Ropanicant
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: CTP2S2911A4B2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No