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SchizophreniaPhase 4PECANSIINCT02339844

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteDenmark
Study dates
Jan 2014to Jan 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • Pregnancy
  • Severe physical illness
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

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

    Copenhagen, Glostrup, 2600

Other trials in 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 after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.

Read the 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.

Conditions
Schizophrenia
Being tested
Aripiprazole
Keywords
glutamate, dopamine, cognition, cortical thickness, ppi, p50
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AripiprazoleDrug

    Also called Abilify

    6 weeks of individual doses of aripiprazole

Study groups in NCT02339844
Study groupRoleWhat they receive
antipsychotic treatmentActive comparatorindividual doses of aripiprazole for all patients
Receives: Drug: Aripiprazole
no treatmentNo interventionno treatment for all healthy controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 weeks, 6 months, 2 years

Secondary outcomes (6)

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

    Thickness of grey matter measured with magnetic resonance and free surfer

    Measured: Baseline, 6 weeks, 6 months & 2 years

  2. Dopamine syntheses capacity in striatum (measured with F-DOPA using Positron emission tomography)

    Dopamine measured with F-DOPA using Positron emission tomography

    Measured: Baseline and 6 weeks follow up

  3. Reward system activation in striatum (measured with functional magnetic resonance imaging)

    Reward activity is measured with functional magnetic resonance imaging

    Measured: Baseline and 6 weeks follow up

  4. 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)

    Measured: Baseline, 6 weeks, 6 months & 2 years

  5. Psychopathology (measured with PANSS (Positive and Negative Syndrome Scale)

    Psychopathology is measured with PANSS (Positive and Negative Syndrome Scale)

    Measured: Baseline, 6 weeks, 6 months & 2 years

  6. 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

    Measured: Baseline, 6 weeks, 6 months & 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2021
  4. Study completionJan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02339844
Sponsor's protocol ID
H-3-2013-149
Acronym
PECANSII
Status last verified
Apr 2021
First submitted
8 Dec 2014
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bojesen KB, Ambrosen KS, Sigvard AK, Nielsen MO, Gjedde A, Kumakura Y, Jensen LT, Fuglo D, Ebdrup BH, Rostrup E, Glenthoj BY. Interrelations between dopaminergic-, gabaergic- and glutamatergic neurotransmitters in antipsychotic-naive psychosis patients and the association to initial treatment response. Mol Psychiatry. 2026 Mar;31(3):1231-1240. doi: 10.1038/s41380-025-03229-0. Epub 2025 Sep 12.

    PubMed 40940558

  • Bojesen KB, Broberg BV, Fagerlund B, Jessen K, Thomas MB, Sigvard A, Tangmose K, Nielsen MO, Andersen GS, Larsson HBW, Edden RAE, Rostrup E, Glenthoj BY. Associations Between Cognitive Function and Levels of Glutamatergic Metabolites and Gamma-Aminobutyric Acid in Antipsychotic-Naive Patients With Schizophrenia or Psychosis. Biol Psychiatry. 2021 Feb 1;89(3):278-287. doi: 10.1016/j.biopsych.2020.06.027. Epub 2020 Jul 10.

    PubMed 32928500

  • Jessen K, Mandl RCW, Fagerlund B, Bojesen KB, Raghava JM, Obaid HG, Jensen MB, Johansen LB, Nielsen MO, Pantelis C, Rostrup E, Glenthoj BY, Ebdrup BH. Patterns of Cortical Structures and Cognition in Antipsychotic-Naive Patients With First-Episode Schizophrenia: A Partial Least Squares Correlation Analysis. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 May;4(5):444-453. doi: 10.1016/j.bpsc.2018.09.006. Epub 2018 Sep 25.

    PubMed 30420252

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy) (time frame: Baseline, 6 weeks, 6 months, 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02339844, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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