This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year

PHASE2TerminatedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 29, 2017

Primary Completion Date

March 17, 2021

Study Completion Date

April 7, 2021

Conditions
Psychotic Disorders
Interventions
DRUG

BI 409306

50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

DRUG

Placebo

placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Trial Locations (33)

10032

New York State Psychiatric Institute, New York

14618

Finger Lakes Clinical Research, Rochester

19104

University of Pennsylvania, Philadelphia

27514

The University of North Carolina at Chapel Hill, Chapel Hill

30912

Augusta University, Augusta

32209

University of Florida College of Medicine, Jacksonville

32763

Medical Research Group of Central Florida, Orange City

37232

Vanderbilt University Medical Center, Nashville

39232

Precise Research Centers, Flowood

45219

University of Cincinnati, Cincinnati

48105

Michigan Clinical Research Institute PC, Ann Arbor

48109

University of Michigan Health System, Ann Arbor

49503

Cherry Health, Grand Rapids

75062

University Hills Clinical Research, Irving

78754

Community Clinical Research, Inc., Austin

84105

Psychiatric and Behavioral Solutions, LLC, Salt Lake City

89102

Altea Research Institute, Las Vegas

90230

ProScience Research Group, Culver City

92103

University of California San Diego, San Diego

97401

PeaceHealth Medical Group, Eugene

100089

Peking University Sixth Hospital, Beijing

200030

Shanghai Mental Health Center, Shanghai

06519

PRIME Clinic, New Haven

02118

Boston Medical Center, Boston

08002

Center For Emotional Fitness, Cherry Hill

T2N 4Z6

University of Calgary, Calgary

T6G 2B7

University of Alberta Hospital (University of Alberta), Edmonton

N7L 1C1

Chatham-Kent Clinical Trials Research Centre, Chatham

L3R 1A3

Alan D. Lowe Medicine Professional Corporation, Toronto

BT41 2RJ

Holywell Hospital, Antrim

B15 2SJ

The Barberry National Centre for Mental Health, Birmingham

SE5 8AF

King's College Hospital, London

M13 9PL

University of Manchester, Manchester

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year | Biotech Hunter | Biotech Hunter