- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01578486
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The specific aims include:
Primary aims:
- Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
- Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.
Secondary aims:
1. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01605
- University of Massaschusetts Medical School
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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:
- Age 18-65 years;
- Diagnosis of schizophrenia or schizoaffective disorder;
- Stable dose of the current antipsychotic drug for at least one month;
- Well established compliance with outpatient treatment per treating clinician's judgment;
- Able to complete the cognitive assessment battery (must be English speaking);
- Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Exclusion Criteria:
- Inability to provide informed consent;
- Current substance abuse;
- Psychiatrically unstable per treating clinician's judgment;
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
- Currently on immunosuppressant medication including oral steroids;
- Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
- History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
- Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
- Pregnancy or breastfeeding;
- Pre-existing chronic tinnitus.
- Known hypersensitivity to salsalate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: salsalate
open-label trial of salsalate 3g/day
|
open-label trial of salsalate 3g/day for 12 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PANSS Total Score
Periodo de tiempo: Baseline and 12 weeks
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Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210).
Higher scores correspond with worse outcomes.
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Baseline and 12 weeks
|
|
SANS Total Score
Periodo de tiempo: Baseline, 12 weeks
|
Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100).
Higher scores correspond with worse outcomes.
|
Baseline, 12 weeks
|
|
MATRICS Composite Score
Periodo de tiempo: Baseline, 12 weeks
|
Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment.
The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition.
A higher score indicates better cognition.
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Baseline, 12 weeks
|
|
PANSS Positive Score
Periodo de tiempo: Baseline, 12 weeks
|
Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms.
The scores range from 7-49, with higher scores representing a worse outcome.
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Baseline, 12 weeks
|
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PANSS- Negative Score
Periodo de tiempo: Baseline, 12 weeks
|
Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms.
The scores range from 7-49, with higher scores representing a worse outcome.
|
Baseline, 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hs-CRP
Periodo de tiempo: Baseline, 12 weeks
|
High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation.
Higher hs-CRP values correspond to higher levels of inflammation.
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Baseline, 12 weeks
|
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TNF-alpha
Periodo de tiempo: Baseline,12 weeks
|
Tumor necrosis-alpha factor will be measured to assess inflammation levels.
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Baseline,12 weeks
|
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IL-6
Periodo de tiempo: Baseline, week 12
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IL-6 (interleukin 6) is a marker used to measure inflammation.
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Baseline, week 12
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xiaoduo Fan, MD, MPH, MS, UMass Medical School
- Director de estudio: Matthew R Goodnow, BS, UMass Medical School
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
- Desordenes mentales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- Desórdenes psicóticos
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Ácido salicilsalicílico
Otros números de identificación del estudio
- 2011-P-000798
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