Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Schizophrenia Clinical Trial

— PECANSII  

Official title:

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339844
• Other study ID #: H-3-2013-149
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: January 2021

Study information

• Verified date: April 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria Patients:

• Fulfilling the diagnostic criteria of schizophrenia or schizoaffective disorder according to ICD-10 (International Classification of Diseases version 10) or DSM-IV/V (Diagnostic and Statistical Manual version 4 /5)
• Age 18-45 years
• Never treated with antipsychotic compounds or central nervous system (CNS) stimulants
• Legally competent

Inclusion criteria controls:

• Matching patients on age (+/- 2 years), sex and parental socioeconomic status
• Age 18-45 years
• No psychiatric or physical disease

Exclusion Criteria patients:

• Substance abuse on a daily basis during the last 3 month or patients fulfilling the criteria of ongoing substance abuse due to ICD-10/DSM-IV/V
• Treatment with antidepressant during the last 30 days
• Head injury with more than 5 minutes of unconsciousness
• Patients involuntarily admitted or treated
• Components of metal implanted by operation
• Pacemaker
• Pregnancy
• Severe physical illness Exclusion criteria controls
• First degree relatives with psychiatric disease
• Substance abuse during the last 3 month or positive screening of drugs in urine-sample
• Head injury with more than 5 minutes of unconsciousness
• Components of metal implanted by operation
• Pacemaker
• Pregnancy
• Severe physical illness

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole
6 weeks of individual doses of aripiprazole

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy)	Glutamate level at baseline and change over time as measured with magnetic resonance spectroscopy	Baseline, 6 weeks, 6 months, 2 years
Secondary	Cortical thickness (measured with magnetic resonance and free surfer)	Thickness of grey matter measured with magnetic resonance and free surfer	Baseline, 6 weeks, 6 months & 2 years
Secondary	Dopamine syntheses capacity in striatum (measured with F-DOPA using Positron emission tomography)	Dopamine measured with F-DOPA using Positron emission tomography	Baseline and 6 weeks follow up
Secondary	Reward system activation in striatum (measured with functional magnetic resonance imaging)	Reward activity is measured with functional magnetic resonance imaging	Baseline and 6 weeks follow up
Secondary	Neurocognition (measured with BACS (Brief Assessment of Cognition in Schizophrenia) and CANTAB (Cambridge Neuropsychological Test Automated Battery)	Neurocognition is measured with BACS (Brief Assessment of Cognition in Schizophrenia) and CANTAB (Cambridge Neuropsychological Test Automated Battery)	Baseline, 6 weeks, 6 months & 2 years
Secondary	Psychopathology (measured with PANSS (Positive and Negative Syndrome Scale)	Psychopathology is measured with PANSS (Positive and Negative Syndrome Scale)	Baseline, 6 weeks, 6 months & 2 years
Secondary	Prepulse inhibition of the startle reflex and reduced P50 suppression ( measured with event related EEG and EMG)	Disturbances in early information processing in form of impaired sensory filtering as measured with event related EEG and EMG	Baseline, 6 weeks, 6 months & 2 years

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