Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)
NCT ID: NCT04846881
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2021-08-24
2024-11-17
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iclepertin
Iclepertin
Iclepertin
Placebo
Placebo
Placebo
Interventions
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Iclepertin
Iclepertin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
50 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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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
Research in Miami Inc
Hialeah, Florida, 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
St 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
Salem VA Medical Center
Salem, Virginia, 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)
Córdoba, , 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
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, , Brazil
Cpquali Pesquisa Clinica Ltda
São Paulo, , Brazil
Clínica Viver - Centro de Desospitalização Humana
São Paulo, , Brazil
Hospital das Clinicas da FMUSP
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.
Pécs, , 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
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
Bełchatów, , 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
Gmina Świecie, , 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 Kneževac, , 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.
Košice, , Slovakia
Psychiatricka Ambulancia Psycholine s.r.o.
Rimavská Sobota, , Slovakia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
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
Benito Menni Complejo Asistencial en Salud Mental
Sant Boi de Llobregat, , Spain
Hospital Virgen del Rocío
Seville, , 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
Countries
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Related Links
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Related Info
Other Identifiers
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2020-003744-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1346-0012
Identifier Type: -
Identifier Source: org_study_id