Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia

NCT00207064 | Completed

• 2 other identifiers: 363055H-KF-01-078/97
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade on these disturbances. We expect disturbances in the serotonergic 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 we expect 5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do not expect any effect of treatment on brain structure

Conditions

Schizophrenia

Keywords

first-episode; altanserin; 5-HT2A receptors; MRI; fMRI; PPI; P300; P50 gating; endophenotypes; vulnerability indicators; quetiapine

Outcome Measures

Primary Outcomes (5)

• 5-HT2A receptor binding and occupancy (PET)

  Baseline and after 6 months

• Structural MRI

  Baseline and after 6 months

• Functional MRI

  Baseline and after 6 months

• Information procession as measured with psychophysiological methods (P300, PPI, P50 gating ect.)

  Baseline and after 6 months

• An extensive battery of neurocognitive measures

  Baseline and after 6 months

Secondary Outcomes (1)

• PANSS

  Baseline and after 6 months

Study Arms (1)

1

EXPERIMENTAL

Drug: quetiapine

Interventions

quetiapine DRUG

flexible doses according to the clinical condition

1

Eligibility Criteria

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

You may qualify if:

• First-episode schizophrenia. The controls are matched for age, gender and parental socioeconomic status

You may not qualify if:

• Previous antipsychotic treatment, mental retardation, organic brain damage, and for the controls a psychiatric diagnosis or first-degree relatives with a psychiatric diagnosis

Sponsors & Collaborators

• Birte Glenthoj: lead
• Rigshospitalet, Denmark: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• The Danish Medical Research Council: collaborator
• Copenhagen Hospital Corporation: collaborator
• University of Copenhagen: collaborator
• AstraZeneca: collaborator

Study Sites (3)

Neurobiology Research Unit, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

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

Glostrup Municipality, DK-2600, Denmark

Location

Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Related Publications (4)

• 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

• Ebdrup BH, Skimminge A, Rasmussen H, Aggernaes B, Oranje B, Lublin H, Baare W, Glenthoj B. Progressive striatal and hippocampal volume loss in initially antipsychotic-naive, first-episode schizophrenia patients treated with quetiapine: relationship to dose and symptoms. Int J Neuropsychopharmacol. 2011 Feb;14(1):69-82. doi: 10.1017/S1461145710000817. Epub 2010 Aug 12.

  PMID: 20701823 DERIVED

• Ebdrup BH, Glenthoj B, Rasmussen H, Aggernaes B, Langkilde AR, Paulson OB, Lublin H, Skimminge A, Baare W. Hippocampal and caudate volume reductions in antipsychotic-naive first-episode schizophrenia. J Psychiatry Neurosci. 2010 Mar;35(2):95-104. doi: 10.1503/jpn.090049.

  PMID: 20184807 DERIVED

• Rasmussen H, Erritzoe D, Andersen R, Ebdrup BH, Aggernaes B, Oranje B, Kalbitzer J, Madsen J, Pinborg LH, Baare W, Svarer C, Lublin H, Knudsen GM, Glenthoj B. Decreased frontal serotonin2A receptor binding in antipsychotic-naive patients with first-episode schizophrenia. Arch Gen Psychiatry. 2010 Jan;67(1):9-16. doi: 10.1001/archgenpsychiatry.2009.176.

  PMID: 20048218 DERIVED

Related Links

• Center for Neuropsychiatric Schizophrenia Research (CNSR)

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Birte Glenthoj, MD, DMSc.

  Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric 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: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychopharmacology and Neuropsychiatry, Danish Center for Neuropsychiatric Schizophrenia Research

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

DK (3)