Neurobiological and Neurocognitive Disturbances in First-Episode Schizophrenia

This study is ongoing, but not recruiting participants.

First Received: September 10, 2005 Last Updated: November 28, 2007 History of Changes

Sponsor:	Bispebjerg Hospital
Collaborators:	Rigshospitalet, Denmark Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital Glostrup University Hospital, Copenhagen The Danish Medical Research Council Copenhagen Hospital Corporation University of Copenhagen AstraZeneca
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00207064

Purpose

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

Condition	Intervention
Schizophrenia	Drug: quetiapine

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Pharmacodynamics Study
Official Title:	5-HT2A-Receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

5-HT2A receptor binding and occupancy (PET) [ Time Frame: prospective ]
Structural MRI [ Time Frame: prospective ]
Functional MRI [ Time Frame: prospective ]
Information procession as measured with psychophysiological methods (P300, PPI, P50 gating ect.) [ Time Frame: prospective ]
An extensive battery of neurocognitive measures [ Time Frame: prospective ]
PANSS [ Time Frame: Prospective ]

Estimated Enrollment:	80
Study Start Date:	April 2004
Estimated Study Completion Date:	July 2008

Intervention Details:

flexible doses

Detailed Description:

Patients and matched healthy controls are examined at baseline and again after the patients have been treated for 6 months with a combined 5-HT2A- and dopamine D2- receptor blocker. We have chosen the atypical antipsychotic compound, quetiapine, for the present study since this drug is characterized by a fast koff/low affinity for the dopamine D2 receptors. The purpose of the study is to examine pathophysiological and neuropsychological mechanisms - not treatment effects. We want to characterize neurobiological and functional endophenotypes or vulnerability indicators and to study their stability over time and their relation to treatment and contemporary psychopathology. To the extent that candidate endophenotypes can be characterized as stable and independent of treatment and contemporary psychopathology they will be analysed together with similar findings from previous (identical)cohorts of schizophrenic patients. Specific disturbances will also be related to candidate genes for schizophrenia.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207064

Locations

Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600
Dept. of Psychiatry O, Rigshospitalet
Copenhagen, Denmark, DK-2100
Dept. of Psychiatry A, Copenhagen County Hospital, Gentofte, Niels Andersensvej 65
Hellerup, Denmark, DK-2900
University of Copenhagen, Dept. of Psychiatry E, Bispebjerg Hospital
Copenhagen NV, Denmark, DK-2400
Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark, DK-2100
Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital
Hvidovre, Denmark, DK-2650

Sponsors and Collaborators

Bispebjerg Hospital

Rigshospitalet, Denmark

Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital

Glostrup University Hospital, Copenhagen

The Danish Medical Research Council

Copenhagen Hospital Corporation

University of Copenhagen

AstraZeneca

Investigators

Study Director:

Birte Glenthoj, MD, DMSc.

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

More Information

Additional Information:

Center for Neuropsychiatric Schizophrenia Research (CNSR) This link exits the ClinicalTrials.gov site

No publications provided by Bispebjerg Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Rasmussen H, Erritzoe D, Andersen R, Ebdrup BH, Aggernaes B, Oranje B, Kalbitzer J, Madsen J, Pinborg LH, Baaré 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.

Study ID Numbers:	363055, 363052-5-HT2A, KF 01-305/99, KF 11-061/03, KF 11-118/03, 2612-2334
Study First Received:	September 10, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00207064 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:

first-episode
altanserin
5-HT2A receptors
MRI
fMRI
PPI

P300
P50 gating
endophenotypes
vulnerability indicators
quetiapine

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010