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Could a daily pill boost brain function in schizophrenia?

NCT ID NCT04846868

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medicine called iclepertin to see if it improves memory and thinking in adults with schizophrenia. About 620 participants took either iclepertin or a placebo daily for 26 weeks, while continuing their usual schizophrenia medications. Researchers measured changes in cognitive function using tests and interviews, comparing results between the two groups.

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

620 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 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 1. Patients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the admission to the trial. 2. Male or female patients who are 18-50 years (inclusive) of age at time of consent. 3. Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) with the following clinical features: * Outpatient, clinically stable and in the residual (non-acute) phase of their illness. * No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. * Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2. 4. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement. 5. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization. \-- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label. Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic. 6. 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. * Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent. * For any other psychoactive medications, doses cannot exceed the maximum daily dose per local label. 7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the protocol. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial. 8. Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interacting with the patient on regular basis, and preferably consistent throughout the study. * The study partner must interact with the subject a minimum 1 hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person. * The study partner must have educational achievement of minimum 8th grade. * Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments. Further inclusion criteria apply. Exclusion criteria 1. Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. Mini International Neuropsychiatric Interview (M.I.N.I.) for Psychotic disorders should be used for guidance. 2. Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy. 3. Severe movement disorders * Leading to cognitive impairment (e.g. Parkinson dementia), or * Interfering with the efficacy assessments, or * Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). 4. Any suicidal behavior in the past 1-year prior to screening and during the screening period. 5. Suicidal ideation of type 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2. \-- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including Visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide. 6. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent. 7. Positive urine drug screen at Visit 1 based on central lab test. 8. Patients who were treated with any of the following within 6 months prior to randomization: * Clozapine * Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil) * Ketamine or esketamine * Electroconvulsive therapy (ECT) or Modified ECT 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

  • "Attikon" University General Hospital of Attica

    Chaïdári, 12462, Greece

  • A.O. Fatebenefratelli

    Milan, 20121, Italy

  • A.O.U. Senese

    Siena, 53100, Italy

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • AX Mental Health Clinic

    Heraklion, 71305, Greece

  • Akademiska sjukhuset

    Uppsala, 751 85, Sweden

  • Akershus Universitetssykehus HF

    Oslo, N-0963, Norway

  • Ankara University Medical School

    Ankara, 06590, Turkey (Türkiye)

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103, United States

  • Asuka Hospital

    Tokyo, Machida, 194-0005, Japan

  • Atlanta Center

    Atlanta, Georgia, 30331, United States

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano (TO), 10043, Italy

  • BR Trials

    São Paulo, 01236-030, Brazil

  • Beijing HuiLongGuan Hospital

    Beijing, 100096, China

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida, 33133, United States

  • CIT-Neuropsique S.C

    Monterrey, 64610, Mexico

  • CPN - Centro de Estudos em Neurociências

    Belo Horizonte, 30150-270, Brazil

  • Celal Bayar Universitesi Tip Fakultesi

    Manisa, 45030, Turkey (Türkiye)

  • Central Teaching Hospital of the Medical University of Lodz

    Lodz, 92-216, Poland

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M6J 1H3, Canada

  • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS

    Bogotá, 111166, Colombia

  • Centro de Investigación y Proyectos en neurociencia CIPNA

    Barranquilla, 80020, Colombia

  • Clinhouse

    Zabrze, 41-807, Poland

  • Clinica Cemelli

    Guadalajara, 44660, Mexico

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845, United States

  • Community Clinical Research, Inc.

    Austin, Texas, 78754, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Dokkyo Medical University Hospital

    Tochigi, Shimotsuga-gun, 321-0293, Japan

  • Dokuz Eylul Universitesi Psikiyatri A.B.D.

    Izmir, 35340, Turkey (Türkiye)

  • E.S.E Hospital Mental de Antioquia

    Bello, 51053, Colombia

  • Eginition Hospital

    Athens, 11528, Greece

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • GabiPros S.C.

    Mexico City, 07000, Mexico

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57 010, Greece

  • General Oncology Hospital "Agioi Anargyri"

    Nea Kifissia, 14564, Greece

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Hino Hospital

    Kanagawa, Yokohama, 234-0051, Japan

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648, Japan

  • Hospital Sao Jose

    Criciúma, 88811-000, Brazil

  • Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)

    Belo Horizonte,Minas Gerais, 31270901, Brazil

  • Hospital de Base - Fac Med de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • Hotei Hospital

    Aichi, Konan, 483-8248, Japan

  • Houston Mind and Brain

    Houston, Texas, 77055, United States

  • InSite Clinical Research

    DeSoto, Texas, 75115, United States

  • Individual Specialist Medical Practice Filip Rybakowski

    Poznan, 60-744, Poland

  • Institute of Living

    Hartford, Connecticut, 06106, United States

  • Institute of Psychiatry and Neurology in Warsaw

    Warsaw, 02-957, Poland

  • Instituto Colombiano del Sistema Nervioso- Clínica Montserrat

    Bogotá, 110121, Colombia

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, 14269, Mexico

  • Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).

    Monterrey, 64710, Mexico

  • Ist. San Raffaele Turro

    Milan, 20127, Italy

  • Istanbul University

    Istanbul, 34093, Turkey (Türkiye)

  • J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria

    Goiânia, 74093-040, Brazil

  • Japan Institute for Health Security National Kohnodai Medical Center

    Chiba, Ichikawa, 272-8516, Japan

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375, Japan

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555, Japan

  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037, Japan

  • Medical Care & Research SA de CV

    Mérida, 97070, Mexico

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023, Japan

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004, Australia

  • National Center of Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851, Japan

  • National Hospital Organization Hizen Psychiatric Medical Center

    Saga, Kanzaki-gun, 842-0192, Japan

  • National Hospital Organization Maizuru Medical Center

    Kyoto, Maizuru, 625-8502, Japan

  • Neuro-Behavioral Clinical Research

    North Canton, Ohio, 44720, United States

  • Neurologie und Psychiatrie / Psychotherapie

    Westerstede, 26655, Germany

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Nishi Kumagaya Hospital

    Saitama, Kumagaya, 360-0816, Japan

  • North Shore Hospital

    Takpuna Auckland, 0622, New Zealand

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104, United States

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Obihiro-Kosei General Hospital

    Hokkaido, Obihiro, 080-0024, Japan

  • Ohwa Mental Clinic

    Tokyo, Toshima-ku, 170-0002, Japan

  • Omega Clinical Trials,LLC

    La Habra, California, 90631, United States

  • PeaceHealth Medical Group

    Eugene, Oregon, 97401, United States

  • Peking University Sixth Hospital

    Beijing, 100089, China

  • Philippine General Hospital

    Manila, Philippines, 1000, Philippines

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756, Poland

  • Praxis Dr. Hahn, Berlin

    Berlin, 13187, Germany

  • Psychiatric Hospital of Attica

    Haidari, 12462, Greece

  • Psykiatriska Kliniken

    Helsingborg, 201 53, Sweden

  • Psynapsis Salud Mental S.A.

    Pereira, 660003, Colombia

  • Richmond Behavioral Associates-Staten Island-68636

    Staten Island, New York, 10314, United States

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495, Japan

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33014, United States

  • Shandong Daizhuang Hospital

    Jining, 272051, China

  • Shanghai Mental Health Center

    Shanghai, 200030, China

  • Shinjuku East Mental Clinic

    Tokyo, Shinjuku-ku, 160-0021, Japan

  • Shiranui Hospital

    Fukuoka, Omuta, 836-0004, Japan

  • Sho Midori Hospital

    Saitama, Saitama, 336-0022, Japan

  • Shounan Hospital

    Nagano, Matsumoto, 390-0847, Japan

  • Showa University Karasuyama Hospital

    Tokyo, Setagaya, 157-8577, Japan

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511, Japan

  • St. Paul's Hospital-Iloilo City-40765

    Iloilo City, 5000, Philippines

  • Sykehuset Østfold HF, avd. Moss

    Moss, N-1535, Norway

  • The Affiliated Brain Hospital of Guangzhou Medical University

    Guangzhou, 510370, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004, China

  • The Affilicated Kangning Hospital of Ningbo University

    Ningbo, 315201, China

  • The First Affilliated Hospital Of Kunming of Medical College

    Kunming, 650032, China

  • The Second Affiliated Hospital of Xinxiang Medical Univ.

    Xinxiang, 453002, China

  • The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province)

    Changsha, 410007, China

  • The sixth People's Hospital of Hebei Province

    Baoding, 71000, China

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503, Japan

  • Tongji Hospital, Tongji University

    Shanghai, 200065, China

  • Trial Tech- Tecnologia em pesquisa com medicamentos

    Curitiba, 80.240-280, Brazil

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636, Greece

  • University at Buffalo, The State University of New York

    Buffalo, New York, 14215, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Yamanashi Hospital

    Yamanashi, Chuo, 409-3898, Japan

  • Velocity Clinical Research-Santa Ana-68902

    Santa Ana, California, 92704, United States

  • Wuxi mental health center

    Wuxi, 214151, China

  • Yamaguchi University Hospital

    Yamaguchi, Ube, 755-8505, Japan

  • Yokohama Onoecho Clinic

    Kanagawa, Yokohama, 231-0015, Japan

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159, Germany

  • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH

    Bad Homburg, 61348, Germany

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