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Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (e-CAeSAR)

4 februari 2016 uppdaterad av: Posit Science Corporation

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

150

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • Palo Alto, California, Förenta staterna, 94304
        • Palo Alto Veteran's Affairs Medical Center
      • San Francisco, California, Förenta staterna, 94108
        • Posit Science Corporation

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
Andra namn:
  • brainhq
Aktiv komparator: Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
Computer games

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
Tidsram: 6 Months
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.
6 Months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Demonstration of equivalency in safety effects reported between treatment groups.
Tidsram: 6 Months
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.
6 Months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Henry W. Mahncke, PhD, Posit Science Corporation
  • Huvudutredare: Richard Keefe, PhD, Schizophrenia Trials Network
  • Huvudutredare: Scott Stroup, MD, MPH, Schizophrenia Trials Network
  • Studierektor: Cate Stasio, Posit Science Corporation

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 mars 2015

Avslutad studie (Faktisk)

1 juni 2015

Studieregistreringsdatum

Först inskickad

22 augusti 2011

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2011

Första postat (Uppskatta)

25 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 februari 2016

Senast verifierad

1 februari 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • BPI-1001-11
  • IRC2MH909833-01 (Annat bidrag/finansieringsnummer: National Institutes of Mental Health)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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