Resumen

Este estudio está abierto a adultos con esquizofrenia. La esquizofrenia puede afectar la forma en que una persona piensa, su memoria y su funcionamiento mental. Los ejemplos incluyen dificultad para recordar cosas, o para leer un libro o prestar atención a una película. Algunas personas tienen dificultad para calcular el cambio correcto o planificar un viaje para llegar a tiempo. El propósito de este estudio es determinar si un medicamento llamado iclepertin mejora el aprendizaje y la memoria en personas con esquizofrenia. Los participantes se asignan a dos grupos de manera aleatoria, lo que significa al azar. Un grupo toma comprimidos de iclepertin y el otro grupo toma comprimidos de placebo. Los comprimidos de placebo tienen el mismo aspecto que los comprimidos de iclepertin pero no contienen ningún medicamento. Los participantes toman un comprimido una vez al día durante 26 semanas. Además, todos los participantes toman su medicación habitual para la esquizofrenia. Durante este tiempo, los médicos evalúan regularmente el aprendizaje y la memoria de los participantes mediante cuestionarios, entrevistas y pruebas computarizadas. Los resultados de las pruebas de capacidad mental se comparan entre los grupos. Los participantes están en el estudio durante aproximadamente 8 meses. Durante este tiempo, visitan el centro del estudio aproximadamente 15 veces y reciben aproximadamente 3 llamadas telefónicas del equipo del estudio. Los médicos también verifican regularmente la salud de los participantes y toman nota de cualquier efecto no deseado.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 50 YearsSexo: ALL

Criterios de inclusión

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.
Male or female patients who are 18-50 years (inclusive) of age at time of consent.
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.
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.
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.
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.
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.
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.

Criterios de exclusión

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.
Cognitive impairment due to developmental, neurological (e.g. stroke) or other disorders including head trauma, or patients with dementia or epilepsy.
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).
Any suicidal behavior in the past 1-year prior to screening and during the screening period.
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.
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.
Positive urine drug screen at Visit 1 based on central lab test.
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

Ubicaciones

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

Ensayo de fase III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, para examinar la eficacia y seguridad de iclepertin una vez al día durante un período de tratamiento de 26 semanas en pacientes con esquizofrenia (CONNEX-2)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Iclepertin

Placebo

Ubicaciones

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

SERES Neurociencia Cognitiva Aplicada

Fundación FunDaMos para la asistencia e investigación en psiquiatría

CEN (Centro Especializado Neurociencias)

Sanatorio Morra S.A.

Clinica Privada de Salud Mental Santa Teresa de Avila

Resolution Psychopharmacology Research Institute

Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

Patrocinadores