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
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|ClinicalTrials.gov Identifier: NCT03230097|
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : April 30, 2021
This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS.
Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day.
During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorders||Drug: BI 409306 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.|
|Actual Study Start Date :||September 29, 2017|
|Actual Primary Completion Date :||March 17, 2021|
|Actual Study Completion Date :||April 7, 2021|
|Experimental: BI 409306||
Drug: BI 409306
|Placebo Comparator: Placebo||
- Time to remission from Attenuated Psychosis Syndrome (APS) [ Time Frame: 52 weeks ]
- Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 24 and 52 weeks of treatment [ Time Frame: Baseline, Week 24 and Week 52 ]
- Change from baseline in the BAC App composite T score after 52 weeks of treatment [ Time Frame: Baseline and Week 52 ]
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) positive items score, negative items score, and total score after 52 weeks of treatment [ Time Frame: Baseline and Week 52 ]
- Time to first episode of psychosis [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230097
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|