BI 409306 in attenuated psychosis syndrome
Research type
Research Study
Full title
Study 1289.32: 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.
IRAS ID
224074
Contact name
Kenneth Scrine
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2016-004973-42
Duration of Study in the UK
3 years, 6 months, 4 days
Research summary
This study tests whether a new medicine called BI 409306 (a Phosphodiesterase-9 inhibitor) 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.
Patients are included in the study once informed consent has been signed. Patients suitable after screening will be allocated at random to the 1 year treatment period and assigned equally to one of two treatment groups; active drug or matching placebo Allocation to treatment groups is based upon a scientific at-risk scoring system and the use of antipsychotic treatments at the start of the study. Treatment groups will be stratified. After completion of the treatment period, or following early discontinuation, patients will complete a 4 week follow-up period.
The study will be conducted in 300 patients from 50 centres by doctors who specialize in treating such patients in hospitals in the USA, Canada and the UK.
Eligible patients will attend the hospital clinic on 14 occasions over a year and take part in a short telephone call at home on 10 occasions. At these visits patients will have their medical history recorded, undergo a routine physical examination, vital signs, height and weight measured, have a standard ECG, routine blood and urine tests and undergo a series of assessment interviews and tests. An optional blood sample will be taken for DNA banking. A video-tape of one of these interviews and an audio recording to analyse voice patterns be made by the study doctor for central assessment by an external expert panel. Patients will need to send a video of themselves each day on a smartphone each time they take their study medication, to an external expert group for assessment. Patients personal details are fully anonymised.
Summary of Results
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.
This is a summary of results from 1 clinical study.We thank all study participants. You helped us to answer important questions about BI 409306 and the treatment of attenuated psychosis syndrome.
What was this study about?
The purpose of this study was to find out whether a medicine called BI 409306 helps people with attenuated psychosis syndrome (APS). Symptoms of APS include having trouble thinking clearly or concentrating, feeling out of control of one’s thoughts, and hearing, seeing, or believing things that others do not. Currently, there is no approved treatment available for APS. BI 409306 is a medicine that is being developed to treat mental disorders.The study was stopped early. This was because it was difficult to find participants willing to be in the study and the COVID-19 pandemic made it even more difficult.
Who took part in this study?
Adolescents and young adults with APS who had never been diagnosed with any other mental disorder could take part in the study.A total of 50 participants took part in this study. There were 25 men and 25 women. The average age was 22 years. The youngest participant was 16 years old, and the oldest participant was 30 years old.
There were participants in Canada, China, and the United States.
How was this study done?
The participants were divided into 2 groups of almost equal size. Every participant had an equal chance of being in each group. The groups were:
• BI 409306 group: participants took 1 tablet of 50 milligrams (mg) BI 409306 twice a day
• Placebo group: participants took 1 tablet of placebo twice a day
Placebo tablets looked like BI 409306 but did not contain any medicine. We compared BI 409306 with placebo to find out how well BI 409306 works. The participants and doctors did not know whether the participants were in the BI 409306 group or in the placebo group.
The participants took BI 409306 or placebo for 1 year.We wanted to find out whether treatment with BI 409306 could help the participants with APS. We looked at the time it took for the participants to be almost or completely free from the symptoms of APS within 1 year of treatment. This is also known as time to remission from APS.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.
What were the results of this study?
The study was stopped early. There were not enough participants to reach clear conclusions about the results of the study.Did participants have any unwanted effects?
Yes, participants in both groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by BI 409306 or placebo. In this study,
20 out of 24 participants (83%) in the BI 409306 group had unwanted effects.
12 out of 26 participants (46%) in the placebo group had unwanted effects.In the BI 409306 group:
• 6 participants (25%) had sensitivity to light (photophobia)
• 5 participants (21%) had dizziness
• 4 participants (17%) had visual impairment
• 3 participants (13%) had headacheIn the placebo group:
• 2 participants (8%) had sensitivity to light (photophobia)
• 0 participants (0%) had dizziness
• 1 participant (4%) had visual impairment
• 5 participants (19%) had headacheNone of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, that they were not life-threatening, and that they did not lead to a disability.
Where can I find more information?
You can find further information about this study at these websites:
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cc05642c926fa495352b908da2d22c76d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637871924632160555%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=UpVPjqcYBwD0o5sdDEZ1ySIpKGK1m2%2BEEfwMKghN0BI%3D&reserved=0 search for the EudraCT number: 2016-004973-42.
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cc05642c926fa495352b908da2d22c76d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637871924632160555%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=36XqLpz%2BiepjW2G43R7beydy5wkVirAFQNmE0iJZGSw%3D&reserved=0 search for the NCT number: NCT03230097.
Boehringer Ingelheim sponsored this study. For contact details, please visit https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cc05642c926fa495352b908da2d22c76d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637871924632160555%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=emFt2acRATa%2Bp3BqE34Ekz816%2BdzSHUeGLmgFTYVml0%3D&reserved=0.The full title of the study is: 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
This study started in October 2017 and was stopped early in April 2021.
Are there additional studies?
If we do more clinical studies with BI 409306, you will find them on the websites listed above. To search for these studies, use the word BI 409306.Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2022 Boehringer Ingelheim International GmbHREC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1714
Date of REC Opinion
21 Nov 2017
REC opinion
Further Information Favourable Opinion