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Could a daily pill sharpen the minds of people with schizophrenia?

NCT ID NCT04860830

Symptom relief Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tested whether iclepertin, a daily tablet, can improve learning and memory in adults with schizophrenia. Over 600 participants took either iclepertin or a placebo for 26 weeks while continuing their usual schizophrenia medication. Researchers measured changes in cognitive function using standardized tests and interviews.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iclepertin (a tablet taken once daily)
What this could lead to
If it works, iclepertin could offer a new way to help people with schizophrenia think more clearly and remember better.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not improve thinking more than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

609 people

The number who actually took part.

Started

Aug 2021

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • A-SHINE s.r.o

    Pilsen, 30100, Czechia

  • AKH - Medical University of Vienna

    Vienna, 1090, Austria

  • Aalborg Universitetsshospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Accel Research Sites Network

    Maitland, Florida, 32751, United States

  • Advanced Medical Research Group Inc

    Hollywood, Florida, 33021, United States

  • Advanced Research Center, Inc.

    Anaheim, California, 92805, United States

  • Arch Clinical Trials, LLC

    St Louis, Missouri, 63141, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Aurora hospital

    Helsinki, 00250, Finland

  • BIND Investigaciones S.C.

    San Luis Potosí City, 78213, Mexico

  • Beijing Anding Hospital

    Beijing, 100088, China

  • Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • Bodmin Community Hospital

    Bodmin, PL31 2QT, United Kingdom

  • CEN (Centro Especializado Neurociencias)

    Córdoba, 5004, Argentina

  • CHA Bundang Medical Center

    Seongnam-si, 13496, South Korea

  • CNRI - Los Angeles

    Pico Rivera, California, 90660, United States

  • CRST - Clinical Research Services Turku

    Turku, 20520, Finland

  • CUP Vivalia -La Clairière

    Bertix, 6880, Belgium

  • Center for Behavioral Health, LLC

    Gaithersburg, Maryland, 20877, United States

  • Centro Medico Luquez

    San Vicente, X5006CBI, Argentina

  • Centro de Investigacion Integral MEDIVEST S.C

    Chihuahua City, 31203, Mexico

  • Centro de Investigación Clinica Acelerada, S.C.

    Mexico City, 07369, Mexico

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

    Culiacán, 80230, Mexico

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333, Taiwan

  • Chang Gung Memorial Hospital-Keelung

    Keelung, 204, Taiwan

  • Chonnam National University Hospital

    Gwangju, 61453, South Korea

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Clinical Hospital Center Dr. Dragisa Misovic

    Belgrade, 11000, Serbia

  • Clínica Privada Banfield

    Banfield, B1828CKR, Argentina

  • Clínica Viver - Centro de Desospitalização Humana

    São Paulo, 04020-060, Brazil

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116, United States

  • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry

    Plovdiv, 4000, Bulgaria

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061, China

  • Fundación FunDaMos para la asistencia e investigación en psiquiatría

    CABA, C1405BOA, Argentina

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

    CABA, C1133AAH, Argentina

  • General Hospital Euromedik

    Belgrade, 11000, Serbia

  • HUS Jorvi Hospital

    Espoo, 2740, Finland

  • Hassman Research Institute-Berlin-60540

    Berlin, New Jersey, 08009, United States

  • Hospital Aranda de la Parra

    León, 37000, Mexico

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Huzhou Third Municipal Hospital

    Huzhou, 313000, China

  • INEP medical s.r.o.

    Prague, 18600, Czechia

  • Iecsi S.C.

    Monterrey, 64310, Mexico

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Instituto Modelo de Neurología Lennox

    Córdoba, X5000FAL, Argentina

  • Instituto Médico DAMIC S.R.L.

    Córdoba, X5003DCE, Argentina

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, 2000, Argentina

  • Instituto de Neurociencias San Agustín

    La Plata, 1900, Argentina

  • Ivetmar Medical Group, LLC

    Miami, Florida, 33155, United States

  • JSC Medical center "Puriena"

    Šilutė, LT-99142, Lithuania

  • JSC Romuvos Clinic

    Kaunas, LT-44279, Lithuania

  • Kai-Syuan Psychiatric Hospital

    Kaohsiung City, 802, Taiwan

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336, Germany

  • LUHS KH Psichiatric Clinic Mariu Division

    Kaunas, LT-53137, Lithuania

  • LWL-Klinik Dortmund

    Dortmund, 44287, Germany

  • LinQ Research, LLC-Richmond-70076

    Richmond, Texas, 77407, United States

  • MP Meditrine s.r.o.

    Ostrava, 708 00, Czechia

  • Maudsley Hospital

    London, SE5 8AZ, United Kingdom

  • Meclinas

    Mechelen, 2800, Belgium

  • Medical Center "Spectar"

    Plovdiv, 4000, Bulgaria

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Midwest Clinical Research

    Dayton, Ohio, 45417, United States

  • Moorgreen Hospital

    Southampton, SO30 3JB, United Kingdom

  • NCKUH

    Tainan, 704, Taiwan

  • Nanjing Brain Hospital

    Nanjing, 210029, China

  • National Institute of Mental Health

    Klecany, 25067, Czechia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nova Psychiatry Inc.

    Orlando, Florida, 32803, United States

  • Oasis Life Care

    State College, Pennsylvania, 16801, United States

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska, 68144, United States

  • PRAGTIS s.r.o.

    Prague, 120 00, Czechia

  • ProScience Research Group

    Culver City, California, 90230, United States

  • Psychiatrie Ricany s.r.o.

    Říčany, 251 01, Czechia

  • Psykiatrisk Center Glostrup

    Glostrup Municipality, 2600, Denmark

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Redesmere

    Chester, CH2 1BQ, United Kingdom

  • Rivus Wellness and Research Institute

    Oklahoma City, Oklahoma, 73112, United States

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060, Brazil

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Shenzhen Kangning Hospital

    Shenzhen, 518003, China

  • Sint-Kamillus

    Bierbeek, 3360, Belgium

  • Special Hospital for Psychiatric Diseases Gornja Toponica

    Gornja Toponica, 18202, Serbia

  • Stanford University Medical Center

    Stanford, California, 94304, United States

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, 71034, Germany

  • Sunwise Clinical Research-Walnut Creek-70166

    Walnut Creek, California, 94596, United States

  • Synexus Clinical Research-Atlanta-67262

    Atlanta, Georgia, 30328, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Taoyuan Psychiatric Center

    Taoyuan, 33058, Taiwan

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050030, China

  • The Fritchie Centre

    Cheltenham, GL53 9DZ, United Kingdom

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630, China

  • Tianjin Anding Hospital

    Tianjin, 300222, China

  • ULS da Região de Leiria, E.P.E.

    Leiria, 2410-197, Portugal

  • ULS de Loures-Odivelas, E.P.E

    Loures, 2674-514, Portugal

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035, Portugal

  • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center

    Raleigh, North Carolina, 27608, United States

  • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

    Duffel, 2570, Belgium

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Vilnius City Mental Health Center

    Vilnius, LT-10309, Lithuania

  • Warneford Hospital

    Oxford, OX3 7JX, United Kingdom

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Xi'an Mental Health Center

    Xi'an, 710101, China

  • Yeungnam University Medical Center

    Daegu, 705-717, South Korea

  • Zhumadian Psychiatric Hospital

    Zhumadian, 463000, China

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