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Cognition, Functioning and Quality of Life

10 de octubre de 2006 actualizado por: Hamilton Health Sciences Corporation

A One-Year Multi-Centre Randomized, Double Blind, Controlled Effectiveness Study of Quetiapine and Olanzapine, Comparing Their Relative Potential in Improving Neuro-Cognitive Deficits, Functional Outcomes and Quality of Life in Schizophrenia

People affected by schizophrenia often experience poor concentration, lapses in memory and difficulty with completing tasks; and this set of problems are known as neuro-cognitive deficits. Traditional medications used in the treatment of schizophrenia have not been particularly useful in improving these problems, while the recently introduced medications are expected to be superior in this respect. The proposed research study is designed to assess the effect of two of the new medications (Zyprexa and Seroquel) in improving the neurocognitive deficits associated with schizophrenia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Schizophrenia is a chronic, debilitating psychiatric disorder with complex clinical presentation, partially responsiveness to treatment and varied outcomes. Though modern anti-psychotic drugs have been used to treat the illness for the past 50 years, it has been consistently observed that a significant proportion of people diagnosed with schizophrenia do not respond adequately to these medications. Even among those people who show symptomatic improvement, the benefit does not translate into improved functioning in real life setting.

Research in the past 10 years revealed two significant findings: 1) it is now known that a proportion of people with schizophrenia have neurocognitive deficits as part of their clinical profile. Neuro-cognitive deficits refer to impairments in attention, concentration, memory, use of language, decision making and subtle aspects of judgment. 2) Traditional antipsychotic drugs have not been useful in improving neurocognitive deficits, while claims have been made that novel antipsychotic drugs (Quetiapine, Olanzapine and Risperidone) may have some beneficial effects in improving the neurocognitive deficits associated with schizophrenia. In an earlier investigation, we have noticed that Quetiapine produced clinically significant improvement in neurocognitive deficits compared to other antipsychotic drugs; and there have been two additional reports confirming this distinctive advantage of Quetiapine.

Based on these preliminary results, the present study is designed to address the following questions. 1) To examine whether the neurocognitive deficits associated with schizophrenia have an impact on the community functioning and quality of life of individuals affected by this illness, and 2) whether Quetiapine (Seroquel) is significantly more effective than Olanzapine (Zyprexa) in improving neurocognitive deficits, community functioning and quality of life.

The study sample will include a total of 120 patients with the diagnosis of schizophrenia or schizoaffective disorder, who will require antipsychotic drug treatment. The sample size calculation is based on the expected differences between the two compared medications, in terms of their ability to improve the neurocognitive cluster score on PANSS (Positive and negative symptoms scale) detected in our earlier study.The study is designed as a prospective double-blind, randomized controlled trial, using Quetiapine and Olanzapine as drugs for comparison. Eligible participants will undergo a baseline clinical and neurocognitive evaluation and randomly assigned to receive either Quetiapine or Olanzapine treatment. Both patients and controls are blinded to the nature of the medication being prescribed. However, the clinicians will have the flexibility to increase the dose as clinically appropriate. The goal is to achieve symptom stability and monitor the progress in community functioning, and changes in perceived quality of life. The participants will continue with the medication at least for a period of one year, and the outcome evaluations will be performed at 1, 3, 6, 9 and 12 month points. These include re-assessment of clinical symptoms and neurocognitive deficits and community functioning, using appropriate measurement tools.

Tipo de estudio

Intervencionista

Inscripción

80

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ontario
      • Hamilton, Ontario, Canadá
        • McMaster University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of schizophrenia confirmed by administering SCID and,
  • Subjects consecutively referred for optimizing antipsychotic drug therapy, i.e. a change of medication from conventional medications or Risperidone is indicated due to lack of efficacy, side-effects or poor subjective tolerability.
  • Competent to provide an informed consent.

Exclusion Criteria:

  • Substance dependence, mental retardation, head injury or other primary neurological disorders.
  • Imminent risk due to suicidal or aggressive behavior (a score of five or more on the hostility item on the PANSS).
  • A pattern of social instability, which could hamper long-term follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Primary outcome measures include changes in neurocognitive test scores, changes in measures of community functioning and quality of life.

Medidas de resultado secundarias

Medida de resultado
Secondary outcomes include changes in treatment adherence, subjective satisfaction with antipsychotic drug therapy, clinical symptoms and side effects.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Lakshmi P Voruganti, MD, McMaster University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2003

Finalización del estudio

1 de marzo de 2006

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2005

Publicado por primera vez (Estimar)

16 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de octubre de 2006

Última actualización enviada que cumplió con los criterios de control de calidad

10 de octubre de 2006

Última verificación

1 de marzo de 2005

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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