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Completed

NCT Number: NCT00207064

Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine

Drug

flexible doses according to the clinical condition

Primary outcomes

  1. 5-HT2A receptor binding and occupancy (PET)

    Time frame: Baseline and after 6 months

  2. Structural MRI

    Time frame: Baseline and after 6 months

  3. Functional MRI

    Time frame: Baseline and after 6 months

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

    Time frame: Baseline and after 6 months

  5. An extensive battery of neurocognitive measures

    Time frame: Baseline and after 6 months

Secondary outcomes

  1. PANSS

    Time frame: Baseline and after 6 months

Sponsors and collaborators

Lead sponsor

Birte Glenthoj

Other

Collaborators

  • AstraZeneca
  • Copenhagen Hospital Corporation
  • Copenhagen University Hospital, Hvidovre
  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark
  • The Danish Medical Research Council
  • University of Copenhagen

Registry information

Official study title

5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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