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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03522220 |
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Date of registration:
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30/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Augmentation of Neuronal Network Plasticity in Schizophrenia
SCZ |
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Scientific title:
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Augmentation of Neuronal Network Plasticity in Schizophrenia |
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Date of first enrolment:
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September 1, 2016 |
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Target sample size:
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150 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03522220 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Maxi Becker, MSc |
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Address:
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Telephone:
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Email:
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max.becker@uke.de |
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Affiliation:
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Name:
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Maxi Becker, MSc. |
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Address:
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Telephone:
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Email:
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max.becker@uke.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- clinically stabilized
- at least one schizophrenic episode in their lives
- International Classification of Diseases 10 (ICD-10) F20.x (and F25)
Exclusion Criteria:
- clinically relevant anemia
- MRI contraindication
- earlier electroconvulsive shock treatment
- significant somatic or neurological disease
- significant alcohol or substance abuse in the year before
- more than 1h video games per day more than 6 months before study start
- simultaneous major psychiatric disease (if symptomatic in the foreground)
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Schizophrenia
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Intervention(s)
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Behavioral: 3D navigation video game intervention
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Behavioral: No 3D navigation
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Behavioral: video game intervention without 3D navigation
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Primary Outcome(s)
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T1 - MRI
[Time Frame: 2 months (= training time and 2 months after training end)]
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Cognition - Spatial Orientation
[Time Frame: 2 months (= training time and 2 months after training end)]
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Positive & Negative Symptoms in patients
[Time Frame: 2 months (= training time and 2 months after training end)]
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Secondary Outcome(s)
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Diffusion Tensor Imaging (DTI)
[Time Frame: 2 month (= training time and 2 month after training end)]
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Spectroscopy - glutamate
[Time Frame: 2 month (= training time and 2 month after training end)]
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Biomarkers (BDNF & interleukin 1 & 6)
[Time Frame: 2 month (= training time and 2 month after training end)]
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Resting State fMRI
[Time Frame: 2 months (= training time and 2 months after training end)]
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Secondary ID(s)
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SFB936 C7
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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