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

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) diagnosis of schizophrenia >= one year prior to randomisation.

Outpatients in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with treating clinician.

Patients currently taking a stable dose of antipsychotic medication(s) for at least 12 weeks prior to randomisation.

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Treatment Details

Interventions

BI 409306 (Other)
Placebo (Other)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 409306 50 mgExperimental Treatment1 Intervention

1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Group II: BI 409306 25 mgExperimental Treatment1 Intervention

1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Group III: PlaceboPlacebo Group1 Intervention

1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.