Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

NCT02339844 | Completed Phase 4 DMC

• 1 other identifier: H-3-2013-149
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

glutamate; dopamine; cognition; cortical thickness; ppi; p50

Outcome Measures

Primary Outcomes (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

  Baseline, 6 weeks, 6 months, 2 years

Secondary Outcomes (6)

• Cortical thickness (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)

  Baseline and 6 weeks follow up

• Reward system activation in striatum (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)

  Baseline, 6 weeks, 6 months & 2 years

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

  Baseline, 6 weeks, 6 months & 2 years

Study Arms (2)

antipsychotic treatment

ACTIVE COMPARATOR

individual doses of aripiprazole for all patients

Drug: Aripiprazole

no treatment

NO INTERVENTION

no treatment for all healthy controls

Interventions

Aripiprazole DRUG

6 weeks of individual doses of aripiprazole

Also known as: Abilify

antipsychotic treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (3)

• 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. 2025 Sep 12. doi: 10.1038/s41380-025-03229-0. Online ahead of print.

  PMID: 40940558 DERIVED

• 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.

  PMID: 32928500 DERIVED

• 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.

  PMID: 30420252 DERIVED

Related Links

• additional information

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Birte Glenthøj, Professor

  Capital Mental Health Services, Center for Neuropsykiatrisk Skizofreniforskning, CNSR & Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: January 16, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)