NCT05212116

A Study of SDI-118 in Participants in Remission From Depression

A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Syndesi Therapeutics · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.

Conditions

• Depression in Remission

Interventions

Type	Name	Description
DRUG	SDI-118	SDI-118 is presented as low dose, and high dose capsules.
DRUG	Placebo	The Matching Placebo for SDI-118 is mannitol in capsules.

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2022-01-27
• Last updated: 2022-04-22

Locations

3 sites across 1 country: United Kingdom