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

NCT05212116 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • P1vital Limited

    collaborator INDUSTRY

  • Syndesi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Katharine Smith, DM · University of Oxford

  • Maeve Duffy, PhD · Syndesi Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-03-11
Completion
2022-03-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212116 on ClinicalTrials.gov