- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Palo Alto, California, Stany Zjednoczone, 94304
- Palo Alto Veteran's Affairs Medical Center
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San Francisco, California, Stany Zjednoczone, 94108
- Posit Science Corporation
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
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Inne nazwy:
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Aktywny komparator: Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
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Computer games
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Demonstration of equivalency in safety effects reported between treatment groups.
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Henry W. Mahncke, PhD, Posit Science Corporation
- Główny śledczy: Richard Keefe, PhD, Schizophrenia Trials Network
- Główny śledczy: Scott Stroup, MD, MPH, Schizophrenia Trials Network
- Dyrektor Studium: Cate Stasio, Posit Science Corporation
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BPI-1001-11
- IRC2MH909833-01 (Inny numer grantu/finansowania: National Institutes of Mental Health)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Plasticity-based Cognitive Training
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University of MiamiUnited States Department of DefenseZakończony
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Ondokuz Mayıs UniversityJeszcze nie rekrutacja
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Cairo UniversityJeszcze nie rekrutacjaPrzewlekła niestabilność stawu skokowego, CAIEgipt
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Ludwig-Maximilians - University of MunichPosit Science CorporationNieznany