Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup
Copenhagen, Glostrup, 2600, Denmark
NCT Number: NCT02339844
The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 4
Copenhagen, Glostrup, 2600, Denmark
The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined at baseline and after 6 weeks, 6 months and 2 years.
Levels of glutamate and gamma-aminobutyric acid (GABA) are measured by proton magnetic resonance spectroscopy (1H-MRS) in the anterior cingulate cortex ACC and thalamus. Presynaptic Dopamine level is measured with Positron Emission Tomography Computed Tomography (PET/CT)-scanning using 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-DOPA). Disturbances of the reward system is measured with functional magnetic resonance imaging (fMRI) . Regional cerebral blood flow and activity in the same regions are measured with Pseudo-continuous arterial spin labelling (pCASL). The default mode network, functional and structural connectivity in the associated macro circuits are measured with resting state fMRI, EEG, and diffusion tensor imaging. Structural brain changes (in grey and white matter) are measured with MRI. Cognitive functions are measured with a neuropsychological test battery, and early information processing with event related EEG and electromyography (EMG) (psychophysiological examinations). Further patients psychopathology will be rated.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Inclusion criteria
controls:
Exclusion criteria
patients:
Exclusion criteria
controls
6 weeks of individual doses of aripiprazole
Other names: Abilify
Time frame: Baseline, 6 weeks, 6 months, 2 years
Glutamate level at baseline and change over time as measured with magnetic resonance spectroscopy
Time frame: Baseline, 6 weeks, 6 months & 2 years
Thickness of grey matter measured with magnetic resonance and free surfer
Time frame: Baseline and 6 weeks follow up
Dopamine measured with F-DOPA using Positron emission tomography
Time frame: Baseline and 6 weeks follow up
Reward activity is measured with functional magnetic resonance imaging
Time frame: Baseline, 6 weeks, 6 months & 2 years
Neurocognition is measured with BACS (Brief Assessment of Cognition in Schizophrenia) and CANTAB (Cambridge Neuropsychological Test Automated Battery)
Time frame: Baseline, 6 weeks, 6 months & 2 years
Psychopathology is measured with PANSS (Positive and Negative Syndrome Scale)
Time frame: Baseline, 6 weeks, 6 months & 2 years
Disturbances in early information processing in form of impaired sensory filtering as measured with event related EEG and EMG
University of Copenhagen
Other
Acronym: PECANSII
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