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Completed

NCT Number: NCT02339844

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup

Copenhagen, Glostrup, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

6 weeks of individual doses of aripiprazole

Other names: Abilify

Primary outcomes

  1. Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy)

    Time frame: Baseline, 6 weeks, 6 months, 2 years

    Glutamate level at baseline and change over time as measured with magnetic resonance spectroscopy

Secondary outcomes

  1. Cortical thickness (measured with magnetic resonance and free surfer)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: PECANSII

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2015
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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