CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia

April 2, 2024 updated by: Boehringer Ingelheim

A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With 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 iclepertin improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

586

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Banfield, Argentina, B1228CKR
      • Caba, Argentina, C1405BOA
        • Recruiting
        • Fundación FunDaMos para la asistencia e investigación en psiquiatría
        • Contact:
      • Caba, Argentina, C1133AAH
        • Recruiting
        • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
        • Contact:
      • Cordoba, Argentina, 5004
        • Recruiting
        • CEN (Centro Especializado Neurociencias)
        • Contact:
      • Cordoba, Argentina, X5003DCE
      • Córdoba, Argentina, X5000FAL
        • Recruiting
        • Instituto Modelo de Neurología Lennox
        • Contact:
      • La Plata, Argentina, 1900
        • Recruiting
        • Instituto de Neurociencias San Agustín
        • Contact:
      • Rosario, Argentina, 2000
        • Recruiting
        • Instituto Médico de la Fundación Estudios Clínicos
        • Contact:
      • San Vicente, Argentina, X5006CBI
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University of Graz State Hospital - University Hospital Graz
        • Contact:
      • Innsbruck, Austria, A-6020
      • Tulln An Der Donau, Austria, 3430
      • Vienna, Austria, 1090
  • Belgium
      • Bertix, Belgium, 6880
        • Active, not recruiting
        • CUP Vivalia -La Clairière
      • Bierbeek, Belgium, 3360
        • Active, not recruiting
        • Sint-Kamillus
      • Duffel, Belgium, 2570
        • Completed
        • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
      • Mechelen, Belgium, 2800
        • Active, not recruiting
        • Meclinas
  • Brazil
      • Rio de Janeiro, Brazil, 22270-060
        • Recruiting
        • Ruschel Medicina e Pesquisa Clínica
        • Contact:
      • Santo André, Brazil, 09080-110
        • Suspended
        • Pesquisare
      • Sao Paulo, Brazil, 04020-060
        • Recruiting
        • Clínica Viver - Centro de Desospitalização Humana
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
        • Contact:
      • Plovdiv, Bulgaria, 4000
      • Sofia, Bulgaria, 1510
      • Sofia, Bulgaria, 1680
      • Sofia, Bulgaria, 1421
        • Recruiting
        • ASMH-IPSMH - Psychiatry - Dr. Georgi Hranov
        • Contact:
  • China
      • Beijing, China, 100088
        • Active, not recruiting
        • Beijing Anding Hospital
      • Changsha, China, 410011
        • Active, not recruiting
        • The Second Xiangya Hospital of Central South University
      • Guangzhou, China, 510630
        • Completed
        • 3rd Affiliated Hosp of Sun yet-sen University
      • Huzhou, China, 313000
        • Active, not recruiting
        • Huzhou Third Municipal Hospital
      • Nanjing, China, 210029
        • Completed
        • Brain Hospital Affiliated to Nanjing Med University
      • Shenzhen, China, 518003
        • Completed
        • Shenzhen Kangning Hospital
      • Shijiazhuang, China, 050030
        • Active, not recruiting
        • The First Hospital Of Hebei Medical University
      • Tianjin, China, 300222
        • Active, not recruiting
        • Tianjin Anding Hospital
      • Xi'an, China, 710061
        • Completed
        • First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, China, 710101
        • Active, not recruiting
        • Xi'an Mental Health Center
      • Zhumadian, China, 463000
        • Active, not recruiting
        • Zhumadian Psychiatric Hospital
  • Czechia
      • Klecany, Czechia, 25067
        • Active, not recruiting
        • National Institute of Mental Health
      • Ostrava-Poruba, Czechia, 708 68
        • Active, not recruiting
        • MPMeditrine s.r.o.
      • Plzen, Czechia, 30100
      • Prague, Czechia, 120 00
        • Completed
        • PRAGTIS s.r.o.
      • Prague, Czechia, 18600
        • Completed
        • INEP medical s.r.o.
      • Ricany, Czechia, 251 01
        • Active, not recruiting
        • Psychiatrie Ricany s.r.o.
  • Denmark
      • Aalborg, Denmark, 9000
        • Active, not recruiting
        • Aalborg Universitetsshospital
      • Aarhus, Denmark, 8200
        • Active, not recruiting
        • Aarhus University Hospital
      • Glostrup, Denmark, 2600
        • Active, not recruiting
        • Psykiatrisk Center Glostrup
  • Finland
      • Espoo, Finland, 2740
        • Active, not recruiting
        • HUS Jorvi Hospital
      • Helsinki, Finland, 00250
        • Active, not recruiting
        • Aurora hospital
      • Turku, Finland, 20520
        • Completed
        • CRST - Clinical Research Services Turku
  • Germany
      • Berlin, Germany, 12627
      • Böblingen, Germany, 71034
        • Recruiting
        • Studienzentrum fur Neurologie und Psychiatrie
        • Contact:
      • Chemnitz, Germany, 09111
        • Recruiting
        • Pharmakologisches Studienzentrum Chemnitz GmbH
        • Contact:
      • Dortmund, Germany, 44287
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • München, Germany, 80336
        • Recruiting
        • Klinikum der Universität München - Campus Innenstadt
        • Contact:
      • Tübingen, Germany, 72076
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Active, not recruiting
        • Inje University Busan Paik Hospital
      • Daegu, Korea, Republic of, 705-717
        • Active, not recruiting
        • Yeungnam University Medical Center
      • Gwangju, Korea, Republic of, 61453
        • Active, not recruiting
        • Chonnam National University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Active, not recruiting
        • Seoul National University Bundang Hospital
      • Seongnam, Korea, Republic of, 13496
        • Completed
        • CHA Bundang Medical Center
      • Yangsan, Korea, Republic of, 50612
        • Completed
        • Pusan National University Yangsan Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-44279
        • Completed
        • JSC Romuvos Clinic
      • Kaunas, Lithuania, LT-53137
        • Active, not recruiting
        • LUHS KH Psichiatric Clinic Mariu Division
      • Silute, Lithuania, LT-99142
        • Completed
        • JSC Medical center "Puriena"
      • Vilnius, Lithuania, LT-10309
        • Active, not recruiting
        • Vilnius City Mental Health Center
  • Mexico
      • Chihuahua, Mexico, 31203
        • Recruiting
        • Centro de Investigacion Integral MEDIVEST S.C
        • Contact:
      • Ciudad de Mexico, Mexico, 07369
        • Recruiting
        • Centro de Investigación Clinica Acelerada, S.C.
        • Contact:
      • Culiacan, Mexico, 80230
        • Recruiting
        • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
        • Contact:
      • Leon, Mexico, 37000
        • Recruiting
        • Hospital Aranda de La Parra
        • Contact:
      • Monterrey, Mexico, 64310
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • San Luis Potosi, Mexico, 78213
        • Recruiting
        • BIND Investigaciones S.C.
        • Contact:
  • Portugal
      • Leiria, Portugal, 2410-197
        • Active, not recruiting
        • ULS da Região de Leiria, E.P.E.
      • Lisboa, Portugal, 1649-035
        • Active, not recruiting
        • ULS de Santa Maria, E.P.E
      • Loures, Portugal, 2674-514
  • Serbia
      • Belgrade, Serbia, 11000
        • Suspended
        • University Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Completed
        • Clinical Hospital Center Dr. Dragisa Misovic
      • Belgrade, Serbia, 11000
        • Completed
        • General Hospital Euromedik
      • Gornja Toponica, Serbia, 18202
        • Active, not recruiting
        • Special Hospital for Psychiatric Diseases Gornja Toponica
      • Kovin, Serbia, 26220
        • Recruiting
        • Special Hospital for Psychiatric Diseases Kovin
        • Contact:
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center of Kragujevac
        • Contact:
  • Taiwan
      • Kaohsiung, Taiwan, 802
        • Recruiting
        • Kai-Syuan Psychiatric Hospital
        • Contact:
      • Keelung, Taiwan, 20401
        • Recruiting
        • Chang Gung Memorial Hospital Keelung
        • Contact:
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
      • Taipei, Taiwan, 10016
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taoyuan, Taiwan, 33058
        • Recruiting
        • Taoyuan Psychiatric Center
        • Contact:
      • Taoyuan County, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital(Linkou)
        • Contact:
  • United Kingdom
      • Bodmin, United Kingdom, PL31 2QT
        • Active, not recruiting
        • Bodmin Community Hospital
      • Cheltenham, United Kingdom, GL53 9DZ
      • Chester, United Kingdom, CH2 1BQ
        • Active, not recruiting
        • Redesmere
      • Edinburgh, United Kingdom, EH4 2XU
        • Active, not recruiting
        • Western General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Completed
        • Queen Elizabeth University Hospital
      • London, United Kingdom, SE5 8AZ
      • Maidstone, United Kingdom, ME16 9PH
      • Oxford, United Kingdom, OX3 7JX
        • Active, not recruiting
        • Warneford Hospital
      • Southampton, United Kingdom, SO30 3JB
        • Completed
        • Moorgreen Hospital
      • York, United Kingdom, YO31 8TA
  • United States
    • California
      • Anaheim, California, United States, 92805
      • Culver City, California, United States, 90230
      • Lafayette, California, United States, 94549
      • Los Angeles, California, United States, 90095
      • Pico Rivera, California, United States, 90660
      • Stanford, California, United States, 94304
    • Florida
      • Hollywood, Florida, United States, 33021
      • Maitland, Florida, United States, 32751
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33155
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Augusta, Georgia, United States, 30912
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Suspended
        • Center for Behavioral Health, LLC
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • North Carolina
      • Raleigh, North Carolina, United States, 27608
        • Recruiting
        • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
        • Contact:
    • Ohio
      • Dayton, Ohio, United States, 45417
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73116
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
    • Texas
      • Houston, Texas, United States, 77030
      • Sugar Land, Texas, United States, 77479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 or epilepsy.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Placebo
Placebo
Experimental: Iclepertin treatment group
Drug: iclepertin
iclepertin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)
Time Frame: 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
After 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score
Time Frame: 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.
After 26 weeks of treatment
Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time Frame: Up to week 26
Up to week 26
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London
Time Frame: Up to week 26
Up to week 26
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
Time Frame: 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.
Up to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2021

Primary Completion (Estimated)

October 26, 2024

Study Completion (Estimated)

November 22, 2024

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1346-0013
  • 2020-003726-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

IPD Sharing Time Frame

After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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