Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT06126497

Run by

Suven Life Sciences Limited

People needed

41

Starts

2024-02-05

Expected to finish

2024-07-19

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Clinical Innovations, Inc — Bellflower, California, United States
• NRC Research Institute — Orange, California, United States
• Collaborative Neuroscience Research, LLC — Torrance, California, United States
• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States
• CenExel iResearch, LLC — Decatur, Georgia, United States
• CenExel iResearch, LLC — Savannah, Georgia, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Neuro behavioral Clinical Research, Inc — North Canton, Ohio, United States
• Cedar Clinical Research, Inc. — Murray, Utah, United States
• Eastside Therapeutic Resource, Inc. dba Core Clinical Research — Everett, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.