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Short Title: BI 409306 in attenuated psychosis syndrome.
Long 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.
EudraCT - 2016-004973-42
ClinicalTrials.gov - NCT03230097
INFORMATION EXTRACTED FROM CLINTRIALS.GOV AND HRA RESEARCH SUMMARIES WEBSITES
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.
Primary Outcome Measures Z : 1.Time to remission from Attenuated Psychosis Syndrome (APS) [ Time Frame: 52 weeks ]
Secondary Outcome Measures Z : 1.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 ]
2.Change from baseline in the BAC App composite T score after 52 weeks of treatment [ Time Frame: Baseline and Week 52 ]
3.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 ]
4.Time to first episode of psychosis [ Time Frame: 52 weeks ]
Extracted from Clinicaltrials.gov
◦Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
◦Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
HRA website entry
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.