- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00694889
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.
Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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Sacramento, California, Forenede Stater, 95817
- University of California, Davis
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San Francisco, California, Forenede Stater, 94143
- University of California, San Francisco
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- First psychotic episode within the last 3 years
- Good general physical health
- Age between 12-35
- Is fluent and proficient in the English language
- Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
- Minors must have parental/legal guardian consent to participate
Exclusion Criteria:
- Any neurological disorder
- History of psychoactive substance abuse in the past 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
Participants will use commercially available computer games.
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The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
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Eksperimentel: 2
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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Neuroadaptiv kognitiv træning omfatter kognitive remedieringsøvelser, som deltagerne vil træne 1 time om dagen, 5 dage om ugen, i 8 uger.
Øvelserne er specifikt designet til at forbedre hastighed og nøjagtighed i opfattelsen af og respons på verbale mål.
Behandlingen vil fokusere på TCT.
|
Aktiv komparator: 3
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
|
Neuroadaptiv kognitiv træning omfatter kognitive remedieringsøvelser, som deltagerne vil træne 1 time om dagen, 5 dage om ugen, i 8 uger.
Øvelserne er specifikt designet til at forbedre hastighed og nøjagtighed i opfattelsen af og respons på verbale mål.
Behandlingen vil fokusere på TCT.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cognitive Performance, as measured by a neuropsychological battery
Tidsramme: Measured at Baseline, Week 8, and 6 Month Follow-Up
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Measured at Baseline, Week 8, and 6 Month Follow-Up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Symptom profile, as measured by clinical interviews
Tidsramme: Measured at Baseline, Week 8, and 6 Month Follow-Up
|
Measured at Baseline, Week 8, and 6 Month Follow-Up
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sophia Vinogradov, MD, University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
- Studieleder: Rachel Loewy, PhD, University of California, San Francisco
- Studieleder: Cameron Carter, MD, University of California, Davis
Publikationer og nyttige links
Generelle publikationer
- Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
- Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
- Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369.
- Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7.
- Roach BJ, Ford JM, Biagianti B, Hamilton HK, Ramsay IS, Fisher M, Loewy R, Vinogradov S, Mathalon DH. Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia. Int J Psychophysiol. 2019 Nov;145:91-98. doi: 10.1016/j.ijpsycho.2018.12.015. Epub 2018 Dec 29.
- Biagianti B, Roach BJ, Fisher M, Loewy R, Ford JM, Vinogradov S, Mathalon DH. Trait aspects of auditory mismatch negativity predict response to auditory training in individuals with early illness schizophrenia. Neuropsychiatr Electrophysiol. 2017;3:2. doi: 10.1186/s40810-017-0024-9. Epub 2017 Jun 9.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06TAF-972
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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