Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

NCT06126497 | Completed Phase 2 FDA Drug

• 1 other identifier: CTP2S1911A4B2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 10

Brief Summary

This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

SUVN-911; Phase-2; MDD; Depression; Open label

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Frequency and severity of adverse events, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.

  From Screening to Day 21

Secondary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS) score.

  From Baseline to Day 14

Study Arms (3)

Ropanicant Dose Level 1

EXPERIMENTAL

The participant will take 1 tablet/day in the morning (for qd dosing)

Drug: Ropanicant

Ropanicant Dose Level 2

EXPERIMENTAL

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Drug: Ropanicant

Ropanicant Dose Level 3

EXPERIMENTAL

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Drug: Ropanicant

Interventions

Ropanicant DRUG

Tablet

Also known as: SUVN-911

Ropanicant Dose Level 1; Ropanicant Dose Level 2; Ropanicant Dose Level 3

Eligibility Criteria

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

You may qualify if:

• Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit.
• Participants must have an MADRS score of ≥25 at the screening and the baseline visits.
• Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.

You may not qualify if:

• Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ).
• Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit.
• Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration.
• Participants who are habitual smokers or using nicotine products.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (10)

Clinical Innovations, Inc

Bellflower, California, 90706, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Collaborative Neuroscience Research, LLC

Torrance, California, 90504, United States

Location

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Neuro behavioral Clinical Research, Inc

North Canton, Ohio, 44720, United States

Location

Cedar Clinical Research, Inc.

Murray, Utah, 84107, United States

Location

Eastside Therapeutic Resource, Inc. dba Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: February 5, 2024
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)