Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02339844
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2014-12-08
Brief Title:
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PECANSII
Brief Summary:
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
Detailed Description:
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 PETCT-scanning using 34-dihydroxy-6-18Ffluoro-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
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 PETCT-scanning using 34-dihydroxy-6-18Ffluoro-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None