Status:
COMPLETED
Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients
Lead Sponsor:
Suven Life Sciences Limited
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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).
Detailed Description
Approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 45 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Follo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06126497
Start Date
February 5 2024
End Date
July 19 2024
Last Update
December 4 2024
Active Locations (10)
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1
Clinical Innovations, Inc
Bellflower, California, United States, 90706
2
NRC Research Institute
Orange, California, United States, 92868
3
Collaborative Neuroscience Research, LLC
Torrance, California, United States, 90504
4
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016