Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients (NCT06836063) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients
United States214 participantsStarted 2025-07-15
Plain-language summary
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
* Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
* Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
* Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
* Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
Exclusion Criteria:
* Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (\<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
* Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
* Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
* Patients with bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG results.
What they're measuring
1
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6