Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

NCT01154829 | Completed

• 1 other identifier: H-D-2008-088
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments.

Conditions

Schizophrenia

Keywords

dopamine; first episode; reward; cognition; MRI; fMRI; PPI; P300; P50 gating; endophenotypes

Outcome Measures

Primary Outcomes (1)

• Relationship between specific neuropsychiatric measures and improvement on PANSS scores

  6 weeks of medical treatment

Secondary Outcomes (6)

• The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade

  Baseline, 6 weeks

• Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade

  Baseline, 2 and 6 weeks, 6,12,24 months

• Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients

  Baseline and 6 weeks follow up

• Structural changes in grey and white matter before and after D2 blockade

  6 weeks, 6, 12 and 24 months,

• Cognitive differences at baseline and changes over time after D2 blockade

  Baseline, 6 weeks, 6,12,24 months

Study Arms (2)

first choice treatment

ACTIVE COMPARATOR

Treatment with amisulpride

Drug: amisulpride

second choice treatment

ACTIVE COMPARATOR

treatment with aripiprazole

Drug: aripiprazole

Interventions

amisulpride DRUG

Individually dosed, according to symptoms, for a period of 6 weeks

Also known as: Solian

first choice treatment

aripiprazole DRUG

Individually dosed, according to symptoms, for a period of 6 weeks

Also known as: abilify

second choice treatment

Eligibility Criteria

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

You may qualify if:

• For patients: meeting diagnostic criteria for schizophrenia according to ICD 10 or DSM IV antipsychotic naive The controls will be matched to the patients according to gender age and parental socio-economic status.

You may not qualify if:

• Patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse
• Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -

Sponsors & Collaborators

• University of Copenhagen: lead
• Glostrup University Hospital, Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Institute of Psychiatry, London: collaborator
• UMC Utrecht: collaborator
• Copenhagen Hospital Corporation: collaborator

Study Sites (1)

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

Glostrup Municipality, DK-2600, Denmark

Location

Related Publications (7)

• Thomas MB, Raghava JM, Pantelis C, Rostrup E, Nielsen MO, Jensen MH, Glenthoj BY, Mandl RCW, Ebdrup BH, Fagerlund B. Associations between cognition and white matter microstructure in first-episode antipsychotic-naive patients with schizophrenia and healthy controls: A multivariate pattern analysis. Cortex. 2021 Jun;139:282-297. doi: 10.1016/j.cortex.2021.03.003. Epub 2021 Mar 18.

  PMID: 33933719 DERIVED

• Wulff S, Nielsen MO, Rostrup E, Svarer C, Jensen LT, Pinborg L, Glenthoj BY. The relation between dopamine D2 receptor blockade and the brain reward system: a longitudinal study of first-episode schizophrenia patients. Psychol Med. 2020 Jan;50(2):220-228. doi: 10.1017/S0033291718004099. Epub 2019 Jan 15.

  PMID: 30642415 DERIVED

• Ebdrup BH, Axelsen MC, Bak N, Fagerlund B, Oranje B, Raghava JM, Nielsen MO, Rostrup E, Hansen LK, Glenthoj BY. Accuracy of diagnostic classification algorithms using cognitive-, electrophysiological-, and neuroanatomical data in antipsychotic-naive schizophrenia patients. Psychol Med. 2019 Dec;49(16):2754-2763. doi: 10.1017/S0033291718003781. Epub 2018 Dec 18.

  PMID: 30560750 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

• Jessen K, Rostrup E, Mandl RCW, Nielsen MO, Bak N, Fagerlund B, Glenthoj BY, Ebdrup BH. Cortical structures and their clinical correlates in antipsychotic-naive schizophrenia patients before and after 6 weeks of dopamine D2/3 receptor antagonist treatment. Psychol Med. 2019 Apr;49(5):754-763. doi: 10.1017/S0033291718001198. Epub 2018 May 8.

  PMID: 29734953 DERIVED

• Anhoj S, Odegaard Nielsen M, Jensen MH, Ford K, Fagerlund B, Williamson P, Glenthoj B, Rostrup E. Alterations of Intrinsic Connectivity Networks in Antipsychotic-Naive First-Episode Schizophrenia. Schizophr Bull. 2018 Oct 17;44(6):1332-1340. doi: 10.1093/schbul/sbx171.

  PMID: 29373756 DERIVED

• Nielsen MO, Rostrup E, Wulff S, Bak N, Broberg BV, Lublin H, Kapur S, Glenthoj B. Improvement of brain reward abnormalities by antipsychotic monotherapy in schizophrenia. Arch Gen Psychiatry. 2012 Dec;69(12):1195-204. doi: 10.1001/archgenpsychiatry.2012.847.

  PMID: 22868877 DERIVED

Related Links

• homepage of the research unit
• homepage of the research unit

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Birte Y Glenthoj, professor

  University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 1, 2010
• Study Start: December 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2016
• Last Updated: May 26, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)