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Could a daily pill boost brain power in schizophrenia?

NCT ID NCT04846881

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a daily medicine called iclepertin can improve memory and thinking in adults with schizophrenia. Over 600 participants took either iclepertin or a placebo for 26 weeks, while continuing their usual schizophrenia medications. Researchers measured cognitive abilities through tests and interviews to see if iclepertin made a difference.

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

611 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 1. Patient must be capable of providing a signed and dated written informed consent by visit 1 in accordance with International Council on Harmonisation for Good Clinical Practice (ICH-GCP) and local legislation prior to 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 hospitalization3 or increase in level of psychiatric care4 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 staying focused, difficulties remembering 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 as needed. * For any other psychoactive medications cannot exceed the maximum daily dose per local label of the country where the study is being conducted. 7. Women of childbearing potential (WOCBP)5 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 patient at a minimum one 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. Patient with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. The 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. stroke) or other disorders including head trauma, or patients with dementia or epilepsy. 3. Severe movement disorders * Leading to cognitive impairment (e.g. Parkinson's 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 Suicidality 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

  • AK Clinic

    Fukuoka, Fukuoka, 810-0031, Japan

  • ASCLEPES Research Centers, P.C. dba Alliance Research

    Long Beach, California, 90807, United States

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626, United States

  • American Medical Research

    Chicago, Illinois, 60612, United States

  • Benito Menni Complejo Asistencial en Salud Mental

    Sant Boi de Llobregat, 08830, Spain

  • Biomedica Research Group

    Santiago, 7500710, Chile

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09715-090, Brazil

  • CEN (Centro Especializado Neurociencias)

    Córdoba, 5004, Argentina

  • CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)

    CABA, 1058AAJ, Argentina

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, S2000QJI, Argentina

  • Centro de Salud de San Juan

    Salamanca, 37005, Spain

  • Centro de Salud mental de Getafe

    Getafe, 28903, Spain

  • Changi General Hospital

    Singapore, 529889, Singapore

  • Chonbuk National University Hospital

    Jeonju, 54907, South Korea

  • Clincal Hospital Centre Rijeka

    Rijeka, 51 000, Croatia

  • Clinhouse

    Zabrze, 41-807, Poland

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata, 1900, Argentina

  • Clinical Center of Vojvodina

    Novi Sad, 21000, Serbia

  • Clinical Hospital Centre Zagreb

    Zagreb, 10 000, Croatia

  • Clinical Innovations, Inc

    Bellflower, California, 90706, United States

  • Clínica Viver - Centro de Desospitalização Humana

    São Paulo, 04020-060, Brazil

  • Collaborative Neuroscience Research, LLC-Torrance-69527

    Torrance, California, 90504, United States

  • Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

    Nove, 25491, Ukraine

  • Connecticut Mental Health Center

    New Haven, Connecticut, 06519, United States

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000, Brazil

  • Daegu Catholic University Medical Center

    Daegu, 42472, South Korea

  • EPAMED s.r.o.

    Košice, 040 01, Slovakia

  • EUROMEDIS Sp. z o.o., Szczecin

    Szczecin, 70-111, Poland

  • Fundación FunDaMos para la asistencia e investigación en psiquiatría

    CABA, C1405BOA, Argentina

  • HOP Albert Chenevier

    Créteil, 94000, France

  • HOP André Mignot

    Le Chesnay-Rocquencourt, 78150, France

  • HOP Carémeau

    Nîmes, 30029, France

  • HOP Charles Perrens

    Bordeaux, 33076, France

  • HOP Fontan

    Lille, 59037, France

  • HOP Gabriel-Montpied

    Clermont-Ferrand, 63003, France

  • HOP Guillaume Régnier

    Rennes, 35703, France

  • HOP Hôtel-Dieu

    Nantes, 44093, France

  • HOP Nord-Saint-Priest-en-Jarez-53664

    Saint-Priest-en-Jarez, 42270, France

  • HOP Pasteur

    Nice, 06000, France

  • HOP Rouffach

    Rouffach, 68250, France

  • HOP la Colombière

    Montpellier, 34295, France

  • Health Center Alcea

    Gdansk, 80-283, Poland

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407, United States

  • Hestia Palau

    Barcelona, 08025, Spain

  • Hirota Clinic

    Fukuoka, Kurume, 830-0033, Japan

  • Hokudai-dori Mental Health Clinic

    Hokkaido, Sapporo, 001-0010, Japan

  • Hokuriku Hospital

    Toyama, Nanto, 939-1893, Japan

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010, Spain

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Nicolás Peña

    Vigo, 36211, Spain

  • Hospital Provincial. Complejo Asistencial de Zamora

    Zamora, 49021, Spain

  • Hospital Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450, Malaysia

  • Hospital Sentosa

    Kuching, 93250, Malaysia

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Hospital Universitario General de Villalba

    Collado de Villalba, 28400, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-010, Brazil

  • Hospital de Son Llàtzer

    Palma, 07198, Spain

  • Inha University Hospital

    Incheon, 400 711, South Korea

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Insight Clinical Trials, LLC, Independence

    Independence, Ohio, 44131, United States

  • Institute for Mental Health

    Belgrade, 11000, Serbia

  • Institute of Mental Health

    Singapore, 539747, Singapore

  • Institute of Science Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8519, Japan

  • Inuo Hospital

    Saga, Tosu, 841-0081, Japan

  • John Peter Smith Health Network

    Fort Worth, Texas, 76104, United States

  • Kanazawa Medical University Hospital

    Ishikwa, Kahoku-gun, 920-0293, Japan

  • Kishi Hospital

    Gumma, Kiryu, 376-0011, Japan

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014, Japan

  • Links Mental Clinic

    Kanagawa, Yokohama, 224-0001, Japan

  • Maastricht University

    Maastricht, 6229 HX, Netherlands

  • Maynds Tower Mental Clinic

    Tokyo, Shibuya-ku, 151-0053, Japan

  • Medical Corporation Seijin Hospital

    Tokyo, Adachi-ku, 121-8515, Japan

  • Medical Corporation Yamadakai Yatsushiro Welfare Hospital

    Kumamoto, Yatsushiro, 866-0043, Japan

  • Mental Health Center Sector 4

    Bucharest, 040872, Romania

  • MentalMEDIC

    Gliwice, 44100, Poland

  • Minami-Aoyama Antique Street Clinic

    Tokyo, Minato-ku, 107-0062, Japan

  • NRC Research Institute

    Orange, California, 92868, United States

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522, Japan

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    Chiba, Chiba, 266-0007, Japan

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

  • Nishigahara Hospital

    Tokyo, Kita-ku, 114-0024, Japan

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Obudai Egeszegugyi Centrum Kft.

    Budapest, 1036, Hungary

  • Okehazama Hospital Fujita Kokoro Care Center

    Aichi, Toyoake, 470-1168, Japan

  • Optimus U Corporation-Miami-69452

    Miami, Florida, 33135, United States

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756, Poland

  • Provincial Hospital for Nervous and Mentally Ill in Swiecie

    Gmina Świecie, 86-100, Poland

  • Psicomed Estudios Clínicos

    Segunda Región, 1270244, Chile

  • PsychCare Consultants Research

    St Louis, Missouri, 63128, United States

  • Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201, Slovakia

  • Psychiatric Doctor's Office Ireneusz Kaczorowski

    Bełchatów, 97-400, Poland

  • Psychiatric Hospital 'Sveti Ivan'

    Zagreb, 10090, Croatia

  • Psychiatricka Ambulancia Psycholine s.r.o.

    Rimavská Sobota, 97901, Slovakia

  • PsychoTech Ltd.

    Pécs, 7633, Hungary

  • Rainbow and Sea Hospital

    Saga, Karatsu, 847-0031, Japan

  • Relaro Medical Trials, LLC

    Dallas, Texas, 75243, United States

  • Research in Miami Inc

    Hialeah, Florida, 33013, United States

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502, Argentina

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060, Brazil

  • SC Carpe Diem SRL

    Sibiu, 557260, Romania

  • SERES Neurociencia Cognitiva Aplicada

    CABA, 1111, Argentina

  • Salem VA Medical Center

    Salem, Virginia, 24153, United States

  • Sanatorio Morra S.A.

    Córdoba, X5009, Argentina

  • Semmelweis University

    Budapest, 1082, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sheppard Pratt Physicians's Practice Association, Inc.

    Baltimore, Maryland, 21204, United States

  • Shinjuku East Mental Clinic

    Tokyo, Shinjuku-ku, 160-0021, Japan

  • Solmed Polyclinic

    Zagreb, 10000, Croatia

  • Special Hospital for Psychiatric Diseases Sveti Vračevi

    Novi Kneževac, 23330, Serbia

  • Suwa Red Cross Hospital

    Nagano, Suwa, 392-8510, Japan

  • Tatsuta Clinic

    Hyogo, Kobe, 651-0097, Japan

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541, Japan

  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513, Japan

  • Uematsu Mental Clinic

    Fukuoka, Chikugo, 833-0041, Japan

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 AV, Netherlands

  • University Psychiatric Hospital Vrapce

    Zagreb, 10090, Croatia

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Debrecen, Gyula Kenezi University Hospital

    Debrecen, 4031, Hungary

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of the Ryukyus Hospital

    Okinawa, Ginowan, 901-2725, Japan

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004, Japan

  • Yuge Neuropsychiatric Hospital

    Kumamoto, Kumamoto, 861-8002, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.