PECANSII: Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT02339844
Collaborator
(none)
130
1
2
84
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: antipsychotic treatment

individual doses of aripiprazole for all patients

Drug: Aripiprazole
6 weeks of individual doses of aripiprazole
Other Names:
  • Abilify
  • No Intervention: no treatment

    no treatment for all healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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)

    5. 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)

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup Copenhagen Glostrup Denmark 2600

    Sponsors and Collaborators

    • University of Copenhagen

    Investigators

    • Study Director: Birte Glenthøj, Professor, Capital Mental Health Services, Center for Neuropsykiatrisk Skizofreniforskning, CNSR & Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Birte Glenthoj, Professor, University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT02339844
    Other Study ID Numbers:
    • H-3-2013-149
    First Posted:
    Jan 16, 2015
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Birte Glenthoj, Professor, University of Copenhagen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2021