Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (NCT06126497) | Clinical Trial Compass
CompletedPhase 2
Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients
United States41 participantsStarted 2024-02-05
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]