ACTIVE_NOT_RECRUITING

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

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Conditions

Major Depressive Disorder (MDD)SUVN-911α4β2RopanicantMDD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-07-15
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06836063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
  3. * Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
  4. * Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
  5. * Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
  1. * 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.
  2. * 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.
  3. * 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.
  4. * Patients with bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG results.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Suven Life Sciences Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • SUVN-911
  • α4β2
  • Ropanicant
  • MDD

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)