RECRUITING

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

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).

Conditions

Major Depressive Disorder (MDD)
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Related Conditions:

Major Depressive Disorder (MDD)

Study Overview

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Study Details

Study overview

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).

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

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

Condition
Major Depressive Disorder (MDD)
Intervention / Treatment

-

Contacts and Locations

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805

Glendale

Behavioral Research Specialists, LLC, Glendale, California, United States, 91206

Oceanside

Excell Research, Inc., Oceanside, California, United States, 92056

Orange

ATP Clinical Research, Orange, California, United States, 92866

Torrance

Collaborative Neuroscience Research, Torrance, California, United States, 90504

Jacksonville

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, United States, 32256

Orlando

Clinical Neuroscience Solutions, Inc., Orlando, Florida, United States, 32801

Tampa

ForCare Clinical Research, Tampa, Florida, United States, 33613

Saint Charles

Midwest Research Group, Saint Charles, Missouri, United States, 63304

Las Vegas

Redbird Research, LLC, Las Vegas, Nevada, United States, 89119

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Suven Life Sciences Limited,

Study Record Dates

2026-02-28