Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-3)
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.
During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.
Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: BI 425809 treatment group
Drug: BI 425809
|Placebo Comparator: Placebo group
Primary Outcome Measures
- Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB) [After 26 weeks of treatment]
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Secondary Outcome Measures
- Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score [After 26 weeks of treatment]
SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
- Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [Up to week 26]
- Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London [Up to week 26]
- Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score [Up to week 24]
PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Signed and dated written informed consent.
Male or female patients who are 18-50 years (inclusive) of age at time of consent.
Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
Patients should have functional impairment in day-to-day activities per investigator judgement.
Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
Women of childbearing potential must use highly effective methods of birth control.
Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.
Patient with current DSM-5 diagnosis other than Schizophrenia.
Cognitive impairment due to other causes, or patients with dementia.
Severe movement disorders.
Any suicidal behavior in past year or suicidal ideation in the past 3 months.
History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
Positive urine drug screen.
Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
Current participation in any investigational drug trial.
Cognitive Remediation Therapy within 12 weeks prior to screening.
Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
Haemoglobin (Hb) below lower limit of normal .
History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
Severe renal impairment.
Indication of liver disease.
Any documented active or suspected malignancy or history of malignancy within 5 years.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Further exclusion criteria apply.
Contacts and Locations
|1||Woodland International Research Group, Inc.||Little Rock||Arkansas||United States||72211|
|2||Advanced Research Center, Inc.||Anaheim||California||United States||92805|
|3||Behavioral Research Specialists, LLC||Glendale||California||United States||91206|
|4||Synergy East||Lemon Grove||California||United States||91945|
|5||University of California Los Angeles||Los Angeles||California||United States||90095|
|6||University of Miami||Miami||Florida||United States||33136|
|7||Synexus Clinical Research||Atlanta||Georgia||United States||30328|
|8||Center for Behavioral Health, LLC||Gaithersburg||Maryland||United States||20877|
|9||Arch Clinical Trials||Saint Louis||Missouri||United States||63125|
|10||Hassman Research Institute||Berlin||New Jersey||United States||08009|
|11||Ben Taub General Hospital||Houston||Texas||United States||77030|
|12||Clínica Privada Banfield||Banfield||Argentina||B1228CKR|
|13||Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)||Caba||Argentina||C1133AAH|
|14||Instituto Médico DAMIC S.R.L.||Cordoba||Argentina||X5003DCE|
|15||Instituto Modelo de Neurología Lennox||Córdoba||Argentina||X5000FAL|
|16||Instituto de Neurociencias San Agustín||La Plata||Argentina||1900|
|17||Instituto Médico de la Fundación Estudios Clínicos||Rosario||Argentina||2000|
|18||CUP Vivalia -La Clairière||Bertix||Belgium||6880|
|20||Universitair Psychiatrisch Centrum Duffel (UPC Duffel)||Duffel||Belgium||2570|
|21||Beijing Anding Hospital||Beijing||China||100088|
|22||The Second Xiangya Hospital Of Central South University||Changsha||China||410011|
|23||Huzhou Third Municipal Hospital||Huzhou||China||313000|
|24||Brain Hospital Affiliated to Nanjing Med University||Nanjing||China||210029|
|25||Shenzhen Kangning Hospital||Shenzhen||China||518003|
|26||The First Hospital of Hebei Medical University||Shijiazhuang||China||050030|
|27||Tianjin Anding Hospital||Tianjin||China||300202|
|28||First Affiliated Hospital of Xi'an JiaoTong University||Xian||China||710061|
|29||Zhumadian Psychiatric Hospital||Zhumadian||China||463000|
|30||Psychiatric Ambulatory - Policlinic Vinicni||Brno||Czechia||615 00|
|31||Neuropsychiatry, s.r.o.||Hradec Kralove||Czechia||500 09|
|32||National Institute of Mental Health||Klecany||Czechia||25067|
|34||PRAGTIS s.r.o.||Prague||Czechia||120 00|
|35||INEP medical s.r.o.||Prague||Czechia||18600|
|37||Aarhus University Hospital||Aarhus||Denmark||8200|
|38||Psykiatrisk Center Glostrup||Glostrup||Denmark||2600|
|39||HUS Jorvi Hospital||Espoo||Finland||2740|
|41||CRST - Clinical Research Services Turku||Turku||Finland||20520|
|42||Studienzentrum für Neurologie und Psychiatrie||Böblingen||Germany||71034|
|43||Pharmakologisches Studienzentrum Chemnitz||Mittweida||Germany||09648|
|44||Klinikum der Universität München - Campus Innenstadt||München||Germany||80336|
|45||Inje University Busan Paik Hospital||Busan||Korea, Republic of||47392|
|46||Chonnam National University Hospital||Gwangju||Korea, Republic of||61453|
|47||CHA Bundang Medical Center||Seongnam||Korea, Republic of||13496|
|48||Seoul National University Bundang Hospital||Seongnam||Korea, Republic of||13620|
|49||Pusan National University Yangsan Hospital||Yangsan||Korea, Republic of||50612|
|50||JSC Romuvos Clinic||Kaunas||Lithuania||LT-44279|
|51||LUHS KH Psichiatric Clinic Mariu Division||Kaunas||Lithuania||LT-53137|
|52||JSC Medical center "Puriena"||Silute||Lithuania||LT-99142|
|53||Vilnius City Mental Health Center||Vilnius||Lithuania||LT-10309|
|54||Centro de Investigacion Integral MEDIVEST S.C||Chihuahua||Mexico||31203|
|55||Centro de Investigación Clinica Acelerada, S.C.||Ciudad de Mexico||Mexico||07369|
|56||Hospital Universitario Dr Jose Eleuterio Gonzalez||Monterrey||Mexico||64460|
|57||BIND Investigaciones S.C.||San Luis Potosi||Mexico||78213|
|58||FSBI of the Moscow region "Psychiatric hospital No. 17"||Moscow||Russian Federation||107076|
|59||Federal State Budget Institution "Mental Health Research Center"||Moscow||Russian Federation||115522|
|60||FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro||St. Petersburg||Russian Federation||192019|
|61||Clinical Center of Serbia||Belgrade||Serbia||11000|
|62||Clinical Hospital Center Dr. Dragisa Misovic||Belgrade||Serbia||11000|
|63||General Hospital Euromedik||Belgrade||Serbia||11000|
|64||Special Hospital for Psychiatric Diseases Kovin||Kovin||Serbia||26220|
|65||Kai-Syuan Psychiatric Hospital||Kaohsiung||Taiwan||802|
|67||National Taiwan University Hospital||Taipei||Taiwan||10016|
|68||Chang Gung Memorial Hospital(Linkou)||Taoyuan County||Taiwan||333|
|69||Taoyuan Psychiatric Center||Taoyuan||Taiwan||33058|
|70||Bodmin Community Hospital||Bodmin||United Kingdom||PL31 2QT|
|71||Redesmere||Chester||United Kingdom||CH2 1BQ|
|72||Queen Elizabeth University Hospital||Glasgow||United Kingdom||G51 4TF|
|73||Moorgreen Hospital||Southampton||United Kingdom||SO30 3JB|
Sponsors and Collaborators
- Boehringer Ingelheim
Study Documents (Full-Text)None provided.