Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
- Registration Number
- NCT02339844
- Lead Sponsor
- University of Copenhagen
- 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 (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description antipsychotic treatment Aripiprazole individual doses of aripiprazole for all patients
- Primary Outcome Measures
Name Time Method Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy) Baseline, 6 weeks, 6 months, 2 years Glutamate level at baseline and change over time as measured with magnetic resonance spectroscopy
- Secondary Outcome Measures
Name Time Method Cortical thickness (measured with magnetic resonance and free surfer) Baseline, 6 weeks, 6 months & 2 years Thickness of grey matter measured with magnetic resonance and free surfer
Dopamine syntheses capacity in striatum (measured with F-DOPA using Positron emission tomography) Baseline and 6 weeks follow up Dopamine measured with F-DOPA using Positron emission tomography
Reward system activation in striatum (measured with functional magnetic resonance imaging) Baseline and 6 weeks follow up Reward activity is measured with functional magnetic resonance imaging
Neurocognition (measured with BACS (Brief Assessment of Cognition in Schizophrenia) and CANTAB (Cambridge Neuropsychological Test Automated Battery) 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)
Psychopathology (measured with PANSS (Positive and Negative Syndrome Scale) Baseline, 6 weeks, 6 months & 2 years Psychopathology is measured with PANSS (Positive and Negative Syndrome Scale)
Prepulse inhibition of the startle reflex and reduced P50 suppression ( measured with event related EEG and EMG) 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
Trial Locations
- Locations (1)
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup
🇩🇰Copenhagen, Glostrup, Denmark