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This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months

NCT03351244 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-05-14

Study results available
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Summary

The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

Conditions

Interventions

DRUG

BI 409306

28 week treatment period

DRUG

Placebo

28 week treatment period

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2021-03-10
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Japan
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03351244 on ClinicalTrials.gov