Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

Phase 3

Completed

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

• Registration Number: NCT04846881
• 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. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also 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: 2021-08-24
• Primary Completion: 2024-10-18
• Study Completion: 2024-11-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iclepertin	Iclepertin	-
Placebo	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 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.
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.

Trial Locations

Locations (127)

Research in Miami Inc; 🇺🇸 Hialeah, Florida, United States

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

Benito Menni Complejo Asistencial en Salud Mental; 🇪🇸 Sant Boi de Llobregat, Spain

Clinical Innovations, Inc; 🇺🇸 Bellflower, California, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

ASCLEPES Research Centers, P.C. dba Alliance Research; 🇺🇸 Long Beach, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Collaborative Neuroscience Research, LLC-Torrance-69527; 🇺🇸 Torrance, California, United States

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States

Optimus U Corporation-Miami-69452; 🇺🇸 Miami, Florida, United States

Health Synergy Clinical Research, LLC; 🇺🇸 West Palm Beach, Florida, United States

American Medical Research; 🇺🇸 Chicago, Illinois, United States

Sheppard Pratt Physicians's Practice Association, Inc.; 🇺🇸 Baltimore, Maryland, United States

PsychCare Consultants Research; 🇺🇸 Saint Louis, Missouri, United States

Neurobehavioral Research, Inc.; 🇺🇸 Cedarhurst, New York, United States

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

Insight Clinical Trials; 🇺🇸 Beachwood, Ohio, United States

Relaro Medical Trials, LLC; 🇺🇸 Dallas, Texas, United States

John Peter Smith Health Network; 🇺🇸 Fort Worth, Texas, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.); 🇦🇷 Caba, Argentina

SERES Neurociencia Cognitiva Aplicada; 🇦🇷 Caba, Argentina

Fundación FunDaMos para la asistencia e investigación en psiquiatría; 🇦🇷 Caba, Argentina

CEN (Centro Especializado Neurociencias); 🇦🇷 Cordoba, Argentina

Sanatorio Morra S.A.; 🇦🇷 Córdoba, Argentina

Clinica Privada de Salud Mental Santa Teresa de Avila; 🇦🇷 La Plata, Argentina

Resolution Psychopharmacology Research Institute; 🇦🇷 Mendoza, Argentina

Centro de Investigacion y Asistencia en Psiquiatria (CIAP); 🇦🇷 Rosario, Argentina

Ruschel Medicina e Pesquisa Clínica; 🇧🇷 Rio de Janeiro, Brazil

Clínica Viver - Centro de Desospitalização Humana; 🇧🇷 Sao Paulo, Brazil

Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos; 🇧🇷 São Bernardo do Campo, Brazil

Cpquali Pesquisa Clinica Ltda; 🇧🇷 São Paulo, Brazil

Biomedica Research Group; 🇨🇱 Santiago, Chile

Psicomed Estudios Clínicos; 🇨🇱 Segunda Región, Chile

Clincal Hospital Centre Rijeka; 🇭🇷 Rijeka, Croatia

Clinical Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Solmed Polyclinic; 🇭🇷 Zagreb, Croatia

Psychiatric Hospital 'Sveti Ivan'; 🇭🇷 Zagreb, Croatia

University Psychiatric Hospital Vrapce; 🇭🇷 Zagreb, Croatia

HOP Charles Perrens; 🇫🇷 Bordeaux, France

HOP Gabriel-Montpied; 🇫🇷 Clermont-Ferrand, France

HOP Albert Chenevier; 🇫🇷 Créteil, France

HOP André Mignot; 🇫🇷 Le Chesnay-Rocquencourt, France

HOP Fontan; 🇫🇷 Lille, France

HOP la Colombière; 🇫🇷 Montpellier, France

HOP Hôtel-Dieu; 🇫🇷 Nantes, France

HOP Pasteur; 🇫🇷 Nice, France

HOP Carémeau; 🇫🇷 Nîmes, France

HOP Guillaume Régnier; 🇫🇷 Rennes, France

HOP Rouffach; 🇫🇷 Rouffach, France

HOP Nord-Saint-Priest-en-Jarez-53664; 🇫🇷 Saint Priest en Jarez, France

Obuda Health Center; 🇭🇺 Budapest, Hungary

Semmelweis University; 🇭🇺 Budapest, Hungary

University of Debrecen, Gyula Kenezi University Hospital; 🇭🇺 Debrecen, Hungary

PsychoTech Ltd.; 🇭🇺 Pecs, Hungary

Okehazama Hospital Fujita Kokoro Care Center; 🇯🇵 Aichi, Toyoake, Japan

Toyota Memorial Hospital; 🇯🇵 Aichi, Toyota, Japan

National Hospital Organization Shimofusa Psychiatric Medical Center; 🇯🇵 Chiba, Chiba, Japan

Uematsu Mental Clinic; 🇯🇵 Fukuoka, Chikugo, Japan

AK Clinic; 🇯🇵 Fukuoka, Fukuoka, Japan

Hirota Clinic; 🇯🇵 Fukuoka, Kurume, Japan

Kishi Hospital; 🇯🇵 Gumma, Kiryu, Japan

Hokudai-dori Mental Health Clinic; 🇯🇵 Hokkaido, Sapporo, Japan

Tatsuta Clinic; 🇯🇵 Hyogo, Kobe, Japan

Kanazawa Medical University Hospital; 🇯🇵 Ishikwa, Kahoku-gun, Japan

Kishiro Mental Clinic; 🇯🇵 Kanagawa, Kawasaki, Japan

Links Mental Clinic; 🇯🇵 Kanagawa, Yokohama, Japan

Yokohama City University Hospital; 🇯🇵 Kanagawa, Yokohama, Japan

Yuge Neuropsychiatric Hospital; 🇯🇵 Kumamoto, Kumamoto, Japan

Medical Corporation Yamadakai Yatsushiro Welfare Hospital; 🇯🇵 Kumamoto, Yatsushiro, Japan

Suwa Red Cross Hospital; 🇯🇵 Nagano, Suwa, Japan

Nara Medical University Hospital; 🇯🇵 Nara, Kashihara, Japan

University of the Ryukyus Hospital; 🇯🇵 Okinawa, Nakagami-gun, Japan

Osaka City Hospital Organization Osaka City General Hospital; 🇯🇵 Osaka, Osaka, Japan

Rainbow and Sea Hospital; 🇯🇵 Saga, Karatsu, Japan

Inuo Hospital; 🇯🇵 Saga, Tosu, Japan

Medical Corporation Seijin Hospital; 🇯🇵 Tokyo, Adachi-ku, Japan

Institute of Science Tokyo Hospital; 🇯🇵 Tokyo, Bunkyo-ku, Japan

Nishigahara Hospital; 🇯🇵 Tokyo, Kita-ku, Japan

Minami-Aoyama Antique Street Clinic; 🇯🇵 Tokyo, Minato-ku, Japan

Toho University Omori Medical Center; 🇯🇵 Tokyo, Ota-ku, Japan

Maynds Tower Mental Clinic; 🇯🇵 Tokyo, Shibuya-ku, Japan

Shinjuku East Mental Clinic; 🇯🇵 Tokyo, Shinjuku-ku, Japan

Hokuriku Hospital; 🇯🇵 Toyama, Nanto, Japan

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Raja Permaisuri Bainun; 🇲🇾 Ipoh, Malaysia

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Sentosa; 🇲🇾 Kuching, Malaysia

Hospital Tuanku Ja'afar; 🇲🇾 Seremban, Negeri Sembilan, Malaysia

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Maastricht University; 🇳🇱 Maastricht, Netherlands

Psychiatric Doctor's Office Ireneusz Kaczorowski; 🇵🇱 Bełchatow, Poland

Podlassian Center of Psychogeriatry, Bialystok; 🇵🇱 Bialystok, Poland

Health Center Alcea; 🇵🇱 Gdansk, Poland

MentalMEDIC; 🇵🇱 Gliwice, Poland

Provincial Hospital for Nervous and Mentally Ill in Swiecie; 🇵🇱 Swiecie, Poland

EUROMEDIS Sp. z o.o., Szczecin; 🇵🇱 Szczecin, Poland

Clinhouse; 🇵🇱 Zabrze, Poland

Mental Health Center Sector 4; 🇷🇴 Bucharest, Romania

SC Carpe Diem SRL; 🇷🇴 Sibiu, Romania

Institute for Mental Health; 🇷🇸 Belgrade, Serbia

Special Hospital for Psychiatric Diseases Sveti Vračevi; 🇷🇸 Novi Knezevac, Serbia

Clinical Center of Vojvodina; 🇷🇸 Novi Sad, Serbia

Changi General Hospital; 🇸🇬 Singapore, Singapore

Institute of Mental Health; 🇸🇬 Singapore, Singapore

Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach; 🇸🇰 Bojnice, Slovakia

EPAMED s.r.o.; 🇸🇰 Kosice, Slovakia

Psychiatricka Ambulancia Psycholine s.r.o.; 🇸🇰 Rimavska Sobota, Slovakia

Hestia Palau; 🇪🇸 Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario General de Villalba; 🇪🇸 Collado De Villalba, Spain

Hospital Universitario Reina Sofía-Córdoba-40500; 🇪🇸 Córdoba, Spain

Centro de Salud mental de Getafe; 🇪🇸 Getafe, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Spain

Hospital de Son Llàtzer; 🇪🇸 Palma, Spain

Centro de Salud de San Juan; 🇪🇸 Salamanca, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Nicolás Peña; 🇪🇸 Vigo, Spain

Hospital Provincial. Complejo Asistencial de Zamora; 🇪🇸 Zamora, Spain

Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council; 🇺🇦 Nove, Ukraine