Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

NCT06836063 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTP2S2911A4B2
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 35

Brief Summary

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).

Conditions

Major Depressive Disorder (MDD)

Keywords

SUVN-911; α4β2; Ropanicant; MDD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6

  Baseline to Week 6

Other Outcomes (1)

• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6

  Baseline to Week 6

Study Arms (3)

Ropanicant Dose Level 1

EXPERIMENTAL

Drug: Ropanicant

Ropanicant Dose Level 2

EXPERIMENTAL

Drug: Ropanicant

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ropanicant DRUG

Tablet dosage form, twice a day

Also known as: SUVN-911

Ropanicant Dose Level 1; Ropanicant Dose Level 2

Placebo DRUG

Matching placebo tablets, twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (35)

Woodland International Research Group LLC

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

ATP Clinical Research

Orange, California, 92866, United States

Location

Collaborative Neuroscience Research

Torrance, California, 90504, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Premier Clinical Research Institute, Inc

Miami, Florida, 33122, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Panhandle Research and Medical Clinic LLC

Pensacola, Florida, 32503, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

CenExcel iResearch LLC

Decatur, Georgia, 30030, United States

Location

CenExcel iResearch LLC

Savannah, Georgia, 31405, United States

Location

Chicago Research Center Inc.

Chicago, Illinois, 60634, United States

Location

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Redbird Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Hassman Research Institue

Marlton, New Jersey, 08053, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research Inc.

Cedarhurst, New York, 11516, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Eximia Research-NC, LLC

Raleigh, North Carolina, 27607, United States

Location

Sooner Clinical Research, Inc

Oklahoma City, Oklahoma, 73116, United States

Location

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

North Texas Clinical Trials, LLC

Fort Worth, Texas, 76104, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 20, 2025
• Study Start: July 15, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (35)