NCT06836063

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of Ropanicant in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US. This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Ropanicant	Tablet dosage form, twice a day
DRUG	Placebo	Matching placebo tablets, twice a day

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-02-23
• Completion: 2026-02-23
• First posted: 2025-02-20
• Last updated: 2026-04-07

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study