- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01422902
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94304
- Palo Alto Veteran's Affairs Medical Center
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San Francisco, California, Stati Uniti, 94108
- Posit Science Corporation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
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Altri nomi:
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Comparatore attivo: Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
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Computer games
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Demonstration of equivalency in safety effects reported between treatment groups.
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Henry W. Mahncke, PhD, Posit Science Corporation
- Investigatore principale: Richard Keefe, PhD, Schizophrenia Trials Network
- Investigatore principale: Scott Stroup, MD, MPH, Schizophrenia Trials Network
- Direttore dello studio: Cate Stasio, Posit Science Corporation
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BPI-1001-11
- IRC2MH909833-01 (Altro numero di sovvenzione/finanziamento: National Institutes of Mental Health)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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