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Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

CompletedPhase 2

Sponsor: Suven Life Sciences Limited

Conditions: Major Depressive Disorder

Interventions: Ropanicant

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (10)

Bellflower, California, United States
Orange, California, United States
Torrance, California, United States
Miami Lakes, Florida, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Flowood, Mississippi, United States
North Canton, Ohio, United States
Murray, Utah, United States
Everett, Washington, United States