Pan European Collaboration on Antipsychotic Naïve Schizophrenia II (PECANSII)

April 27, 2021 updated by: Birte Glenthoj, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Centre Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 weeks, 6 months, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 weeks, 6 months & 2 years
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
Baseline and 6 weeks follow up
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
Baseline and 6 weeks follow up
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)
Baseline, 6 weeks, 6 months & 2 years
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)
Baseline, 6 weeks, 6 months & 2 years
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
Baseline, 6 weeks, 6 months & 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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