Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (e-CAeSAR)
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach
This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive remediation treatment versus a computer-based control.
The investigators proposed that a computerized cognitive remediation program based upon the principles of brain plasticity may improve information processing and thus drive clinically significant improvements in cognitive and functional performance in individuals with schizophrenia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The symptoms of schizophrenia fall into three main categories: positive symptoms, negative symptoms, and cognitive symptoms. Each category represents distinct functional challenges and impedes patient productivity and overall quality of life.
Cognitive symptoms are pervasive and result in deficits in executive functioning (the ability to understand information and use it to make decisions), attention (the ability to identify, select, and focus on relevant sensory events), and working memory (the ability to hold information in memory and then guide actions from it). These symptoms impair patients' abilities to successfully perform everyday activities, including independent living, employment, and social relationships, and in addition can cause great emotional distress.
Cognitive impairment in schizophrenia has now received substantial academic study, with over 24,000 research papers published in the field since 1990. This enormous body of work has shown that cognitive impairment is likely to be present in virtually all patients with schizophrenia, regardless of their severity of illness or treatment status. People with schizophrenia typically perform 1-2 standard deviations below the mean of age-matched controls (indicating substantial impairment) across the domains of speed of information processing, attention, working memory, verbal and visual learning, reasoning and social cognition.
While cognitive impairment in schizophrenia was originally assumed to be secondary to positive or negative symptoms of the disorder, or related to the use of anti-psychotic medications, recent research has conclusively shown that neither of these past assumptions is true. For example, the landmark Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial involving 1,493 participants demonstrated that negative symptoms are only mildly correlated with cognitive function, and that positive symptoms are completely uncorrelated with cognitive function. Furthermore, research has shown that cognitive impairment is evident in people with schizophrenia before they are medicated, prior to diagnosis, and in first-degree relatives of people diagnosed with schizophrenia; indicating that medication is not the cause of cognitive impairment. In aggregate, these data have established the well-accepted current viewpoint that cognitive dysfunction is a core primary symptom and deficit in schizophrenia.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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Palo Alto, California, Estados Unidos, 94304
- Palo Alto Veteran's Affairs Medical Center
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San Francisco, California, Estados Unidos, 94108
- Posit Science Corporation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 18 years of older with confirmed diagnosis of Schizophrenia
- Adequate decisional and reading capacity
- Clinical stable
- Moderate or less severity on Positive and Negative Symptoms Scale
- English speaker
- Capable of completing clinical and cognitive assessment battery
- Lack of visual, auditory or motor capacity to participate in the study
- Minimal level of extrapyramidal symptoms
- Minimal level of depressive symptoms
Exclusion Criteria:
- Failure to meet suicidality rating criteria
- Prescribed greater than 2 anti-psychotics
- Significant alcohol and illicit drug use
- History of mental retardation or pervasive developmental disorder or other neurological disorder
- Prior specified computer-based cognitive remediation training
- Participation in a concurrent study that could affect the outcome of this one
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
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Outros nomes:
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Comparador Ativo: Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
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Computer games
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
Prazo: 6 Months
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Each outcome score (MCCB composite score and UPSA-2 total score) will be analyzed separately.
The treatment efficacy will be established if and only if both tests on MCCB and UPSA-2 are significant at two-sided alpha level of 0.05.
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6 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Demonstration of equivalency in safety effects reported between treatment groups.
Prazo: 6 Months
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Positive and Negative Symptom Scale (PANSS) positive symptom scale, negative symptom scale and total scale will be assessed at study mid-point and study end.
Adverse effects by treatment group will also be assessed at study mid-point and study end.
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6 Months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Henry W. Mahncke, PhD, Posit Science Corporation
- Investigador principal: Richard Keefe, PhD, Schizophrenia Trials Network
- Investigador principal: Scott Stroup, MD, MPH, Schizophrenia Trials Network
- Diretor de estudo: Cate Stasio, Posit Science Corporation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BPI-1001-11
- IRC2MH909833-01 (Número de outro subsídio/financiamento: National Institutes of Mental Health)
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