Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

NCT ID: NCT04846868

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2024-10-01

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 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Iclepertin 10 mg

Patients with schizophrenia took orally once a day one 10 milligram (mg) tablet of iclepertin.

Group Type: EXPERIMENTAL

Iclepertin

Intervention Type: DRUG

One 10 milligram (mg) tablet once a day.

Placebo-matching Iclepertin 10 mg

Patients with schizophrenia took orally once a day one tablet of placebo-matching iclepertin.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One tablet once a day.

Interventions

Iclepertin

One 10 milligram (mg) tablet once a day.

Intervention Type: DRUG

Placebo

One tablet once a day.

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Collaborative Neuroscience Network, LLC (CNS)

Garden Grove, California, United States

Omega Clinical Trials,LLC

La Habra, California, United States

Artemis Institute for Clinical Research, LLC

San Diego, California, United States

Velocity Clinical Research-Santa Ana-68902

Santa Ana, California, United States

Institute of Living

Hartford, Connecticut, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

CCM Clinical Research Group, LLC-Miami-68482

Miami, Florida, United States

Atlanta Center

Atlanta, Georgia, United States

University at Buffalo, The State University of New York

Buffalo, New York, United States

Richmond Behavioral Associates-Staten Island-68636

Staten Island, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

PeaceHealth Medical Group

Eugene, Oregon, United States

Community Clinical Research, Inc.

Austin, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

Houston Mind and Brain

Houston, Texas, United States

Core Clinical Research

Everett, Washington, United States

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

CPN - Centro de Estudos em Neurociências

Belo Horizonte, , Brazil

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

Belo Horizonte,Minas Gerais, , Brazil

Hospital Sao Jose

Criciúma, , Brazil

Trial Tech- Tecnologia em pesquisa com medicamentos

Curitiba, , Brazil

J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria

Goiânia, , Brazil

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

São José do Rio Preto, , Brazil

BR Trials

São Paulo, , Brazil

University of Calgary

Calgary, Alberta, Canada

OCT Research ULC

Kelowna, British Columbia, Canada

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

The sixth People's Hospital of Hebei Province

Baoding, , China

Peking University Sixth Hospital

Beijing, , China

Beijing HuiLongGuan Hospital

Beijing, , China

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

Changsha, , China

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, , China

The Affiliated Hospital of Guizhou Medical University

Guiyang, , China

Shandong Daizhuang Hospital

Jining, , China

The First Affilliated Hospital Of Kunming of Medical College

Kunming, , China

The Affilicated Kangning Hospital of Ningbo University

Ningbo, , China

Shanghai Mental Health Center

Shanghai, , China

Tongji Hospital, Tongji University

Shanghai, , China

Wuxi mental health center

Wuxi, , China

The Second Affiliated Hospital of Xinxiang Medical Univ.

Xinxiang, , China

Centro de Investigación y Proyectos en neurociencia CIPNA

Barranquilla, , Colombia

E.S.E Hospital Mental de Antioquia

Bello, , Colombia

Instituto Colombiano del Sistema Nervioso- Clínica Montserrat

Bogotá, , Colombia

Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS

Bogotá, , Colombia

Psynapsis Salud Mental S.A.

Pereira, , Colombia

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

Bad Homburg, , Germany

Praxis Dr. Hahn, Berlin

Berlin, , Germany

Zentralinstitut für seelische Gesundheit

Mannheim, , Germany

Neurologie und Psychiatrie / Psychotherapie

Westerstede, , Germany

Eginition Hospital

Athens, , Greece

"Attikon" University General Hospital of Attica

Chaïdári, , Greece

Psychiatric Hospital of Attica

Haidari, , Greece

AX Mental Health Clinic

Heraklion, , Greece

General Oncology Hospital "Agioi Anargyri"

Nea Kifissia, , Greece

University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, , Greece

ASST degli Spedali Civili di Brescia

Brescia, , Italy

A.O. Fatebenefratelli

Milan, , Italy

Ist. San Raffaele Turro

Milan, , Italy

Azienda Sanitaria Ospedale S. Luigi Gonzaga

Orbassano (TO), , Italy

A.O.U. Senese

Siena, , Italy

Hotei Hospital

Aichi, Konan, , Japan

Japan Institute for Health Security National Kohnodai Medical Center

Chiba, Ichikawa, , Japan

Mental Clinic Sakurazaka

Fukuoka, Fukuoka, , Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, , Japan

Kuramitsu Hospital

Fukuoka, Fukuoka, , Japan

Shiranui Hospital

Fukuoka, Omuta, , Japan

Obihiro-Kosei General Hospital

Hokkaido, Obihiro, , Japan

Hokkaido University Hospital

Hokkaido, Sapporo, , Japan

St. Marianna University Hospital

Kanagawa, Kawasaki, , Japan

Kitasato University Hospital

Kanagawa, Sagamihara, , Japan

Yokohama Onoecho Clinic

Kanagawa, Yokohama, , Japan

Hino Hospital

Kanagawa, Yokohama, , Japan

Kochi Health Sciences Center

Kochi, Kochi, , Japan

National Hospital Organization Maizuru Medical Center

Kyoto, Maizuru, , Japan

Tohoku University Hospital

Miyagi, Sendai, , Japan

Shounan Hospital

Nagano, Matsumoto, , Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, , Japan

National Hospital Organization Hizen Psychiatric Medical Center

Saga, Kanzaki-gun, , Japan

Saitama Medical University Hospital

Saitama, Iruma-gun, , Japan

Nishi Kumagaya Hospital

Saitama, Kumagaya, , Japan

Sho Midori Hospital

Saitama, Saitama, , Japan

Dokkyo Medical University Hospital

Tochigi, Shimotsuga-gun, , Japan

Tokushima University Hospital

Tokushima, Tokushima, , Japan

National Center of Neurology and Psychiatry

Tokyo, Kodaira, , Japan

Asuka Hospital

Tokyo, Machida, , Japan

Showa University Karasuyama Hospital

Tokyo, Setagaya, , Japan

Shinjuku East Mental Clinic

Tokyo, Shinjuku-ku, , Japan

Ohwa Mental Clinic

Tokyo, Toshima-ku, , Japan

Yamaguchi University Hospital

Yamaguchi, Ube, , Japan

University of Yamanashi Hospital

Yamanashi, Chuo, , Japan

Clinica Cemelli

Guadalajara, , Mexico

GabiPros S.C.

Mexico City, , Mexico

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, , Mexico

Medical Care & Research SA de CV

Mérida, , Mexico

CIT-Neuropsique S.C

Monterrey, , Mexico

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

Monterrey, , Mexico

North Shore Hospital

Takpuna Auckland, , New Zealand

Sykehuset Østfold HF, avd. Moss

Moss, , Norway

Akershus Universitetssykehus HF

Oslo, , Norway

St. Paul's Hospital-Iloilo City-40765

Iloilo City, , Philippines

Philippine General Hospital

Manila, Philippines, , Philippines

Podlassian Center of Psychogeriatry, Bialystok

Bialystok, , Poland

Central Teaching Hospital of the Medical University of Lodz

Lodz, , Poland

Individual Specialist Medical Practice Filip Rybakowski

Poznan, , Poland

Institute of Psychiatry and Neurology in Warsaw

Warsaw, , Poland

Clinhouse

Zabrze, , Poland

Psykiatriska Kliniken

Helsingborg, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Ankara University Medical School

Ankara, , Turkey (Türkiye)

Istanbul University

Istanbul, , Turkey (Türkiye)

Dokuz Eylul Universitesi Psikiyatri A.B.D.

Izmir, , Turkey (Türkiye)

Celal Bayar Universitesi Tip Fakultesi

Manisa, , Turkey (Türkiye)

Countries

United States; Australia; Brazil; Canada; China; Colombia; Germany; Greece; Italy; Japan; Mexico; New Zealand; Norway; Philippines; Poland; Sweden; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2020-003760-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1346-0011

Identifier Type: -

Identifier Source: org_study_id