- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00825539
Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90073
- West LA VA Healthcare Center (UCLA)
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
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Maryland
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Baltimore, Maryland, Estados Unidos, 21228
- Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Massachusetts General Hospital (Freedom Trail Clinic)
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University
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North Carolina
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Butner, North Carolina, Estados Unidos, 27509
- JUH Clinical Research (Duke University),
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV/DSM IV TR)
- Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
Subjects will meet the following symptom criteria:
- Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item scores less than or equal to 5
- BPRS Conceptual Disorganization item score less than or equal to 4
- Simpson-Angus Scale (SAS) total score less than or equal to 6
- Calgary Depression Scale (CDS) total score less than or equal to 10
Subjects will meet the following cognitive performance criteria:
- Maximum performance level: Performance below 1.0 SD from perfect performance on the Hopkins Verbal Learning Test (HVLT) total (31 or less),
- Minimum performance level: subject must be able to validly complete the fMRI cognitive paradigms
- WTAR: 5th grade reading level assessment
- Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
- Male subjects must be using two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the studyuntil the Study Completion visit.
- Subject must have sufficiently stable overall health, as determined by the Investigator. The regular intake of concomitant drugs will be allowed, if the patient is on stable treatment for at least 3 months prior to study enrollment and the concomitant drug does not belong to the list of medication that are not allowed according to Appendix 3. If the patient takes more than one concomitant medication, it is at the Investigator's discretion to decide about the patient's eligibility, depending on the nature of the concomitant medications and the patient's overall health.
Exclusion criteria:
- Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
- Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
Subjects with a history of significant head injury/trauma, as defined by:
- Loss of consciousness (LOC) for more than 1 hour
- Recurring seizures resulting from the head injury
- Clear cognitive sequelae of the injury
- Cognitive rehabilitation following the injury
- Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
- Use of certain concomitant medication
No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
Other protocol-defined inclusion/exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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Experimental: AQW051
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
Periodo de tiempo: 2 years (Part 1: 1 year)
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2 years (Part 1: 1 year)
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Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
Periodo de tiempo: Part 2: 8 months
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Part 2: 8 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
Periodo de tiempo: Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
Periodo de tiempo: 2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
Periodo de tiempo: 2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
Periodo de tiempo: 2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAQW051A2202
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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