Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-3)

Boehringer Ingelheim (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

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
  • Drug: BI 425809
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
586 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-3)
Actual Study Start Date :
Jun 18, 2021
Anticipated Primary Completion Date :
Apr 5, 2024
Anticipated Study Completion Date :
May 3, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 425809 treatment group

Drug: BI 425809
BI 425809

Placebo Comparator: Placebo group

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [Up to week 26]

  3. Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London [Up to week 26]

  4. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:

Inclusion criteria

  • 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.

Exclusion criteria

  • 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


Site City State Country Postal Code
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
19 Sint-Kamillus Bierbeek Belgium 3360
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
33 A-SHINE s.r.o Plzen Czechia 30100
34 PRAGTIS s.r.o. Prague Czechia 120 00
35 INEP medical s.r.o. Prague Czechia 18600
36 Aalborg Universitetsshospital Aalborg Denmark 9000
37 Aarhus University Hospital Aarhus Denmark 8200
38 Psykiatrisk Center Glostrup Glostrup Denmark 2600
39 HUS Jorvi Hospital Espoo Finland 2740
40 Aurora hospital Helsinki Finland 00250
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
66 NCKUH Tainan Taiwan 704
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


None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Boehringer Ingelheim Identifier:
Other Study ID Numbers:
  • 1346-0013
  • 2020-003726-23
First Posted:
Apr 27, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022