Schizophrenia Clinical Trial
— PECANSIIOfficial title:
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Verified date | April 2021 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup | Copenhagen | Glostrup |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
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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