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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Iclepertin; Drug: Placebo

• Registration Number: NCT04846868
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Study Start: 2021-09-08
• Primary Completion: 2024-09-17
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iclepertin arm	Iclepertin	-
Placebo arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment	at baseline and at week 26	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment	at baseline and at week 26	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.
Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	at baseline and at week 26
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test	at baseline and at week 26
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score	up to 24 weeks	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.

Trial Locations

Locations (116)

Hospital de Base - Fac Med de Sao Jose do Rio Preto; 🇧🇷 Sao Jose do Rio Preto, Brazil

BR Trials; 🇧🇷 Sao Paulo, Brazil

University General Hospital of Thessaloniki AHEPA; 🇬🇷 Thessaloniki, Greece

General Hospital of Thessaloniki "G. Papanikolaou"; 🇬🇷 Thessaloniki, Greece

Yamaguchi University Hospital; 🇯🇵 Yamaguchi, Ube, Japan

University of Yamanashi Hospital; 🇯🇵 Yamanashi, Chuo, Japan

GabiPros S.C.; 🇲🇽 Cdmx, Mexico

Instituto Nacional de Neurologia y Neurocirugia; 🇲🇽 Ciudad de Mexico, Mexico

Clinica Cemelli; 🇲🇽 Guadalajara, Mexico

Medical Care & Research SA de CV; 🇲🇽 Merida, Mexico

CIT-Neuropsique S.C; 🇲🇽 Monterrey, Mexico

Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).; 🇲🇽 Monterrey, Mexico

North Shore Hospital, Takapuna; 🇳🇿 Takpuna Auckland, New Zealand

Sykehuset Østfold HF, avd. Moss; 🇳🇴 Moss, Norway

Akershus Universitetssykehus HF; 🇳🇴 Oslo, Norway

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

Ankara University Medical School; 🇹🇷 Ankara, Turkey

Istanbul University; 🇹🇷 Istanbul, Turkey

Dokuz Eylul Universitesi Psikiyatri A.B.D.; 🇹🇷 Izmir, Turkey

Celal Bayar Universitesi Tip Fakultesi; 🇹🇷 Manisa, Turkey

Ohwa Mental Clinic; 🇯🇵 Tokyo, Toshima-ku, Japan

Velocity Clinical Research-Santa Ana-68902; 🇺🇸 Santa Ana, California, United States

CCM Clinical Research Group, LLC-Miami-68482; 🇺🇸 Miami, Florida, United States

Richmond Behavioral Associates-Staten Island-68636; 🇺🇸 Staten Island, New York, United States

St. Paul's Hospital-Iloilo City-40765; 🇵🇭 Iloilo City, Philippines

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

Institute of Living; 🇺🇸 Hartford, Connecticut, United States

San Marcus Research Clinic, Inc.; 🇺🇸 Miami, Florida, United States

Atlanta Center; 🇺🇸 Atlanta, Georgia, United States

University at Buffalo, The State University of New York; 🇺🇸 Buffalo, 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

Hospital das Clinicas da Universidade Federal HC-UFMG; 🇧🇷 Belo Horizonte,Minas Gerais, Brazil

CPN - Centro de Estudos em Neurociências; 🇧🇷 Belo Horizonte, Brazil

Hospital Sao Jose; 🇧🇷 Criciuma, Brazil

Trial Tech- Tecnologia em pesquisa com medicamentos; 🇧🇷 Curitiba, Brazil

J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria; 🇧🇷 Goiania, 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

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; 🇨🇴 Bogota, 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; 🇬🇷 Chaidari, Greece

Psychiatric Hospital of Attica; 🇬🇷 Haidari, Greece

AX Mental Health Clinic; 🇬🇷 Heraclion, Greece

General Oncology Hospital "Agioi Anargyri"; 🇬🇷 Nea Kifisia, Greece

ASST degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

A.O. Fatebenefratelli; 🇮🇹 Milano, Italy

Ist. San Raffaele Turro; 🇮🇹 Milano, Italy

Azienda Sanitaria Ospedale S. Luigi Gonzaga; 🇮🇹 Orbassano (to), Italy

A.O.U. Senese Policlinico Santa Maria alle Scotte; 🇮🇹 Siena, Italy

Hotei Hospital; 🇯🇵 Aichi, Konan, Japan

National Center for Global Health and Medicine Kohnodai Hospital; 🇯🇵 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