NCT06126497

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 Dose 1 qd, Dose 2 bid, or Dose 3 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Ropanicant	Tablet

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2023-11-13
• Last updated: 2026-04-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study