Clinical trial NCT00694889: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Official title: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Psychosis
First Episode
Schizophrenia
Cognitive Remediation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2008-06-11
Enrollment: 144
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Performance, as measured by a neuropsychological battery
timeFrame: Measured at Baseline, Week 8, and 6 Month Follow-Up
Secondary outcomes:
measure: Symptom profile, as measured by clinical interviews
timeFrame: Measured at Baseline, Week 8, and 6 Month Follow-Up
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Rachel Loewy, PhD
role: STUDY_DIRECTOR
affiliation: University of California, Davis
name: Cameron Carter, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.