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Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen University Hospital, Hvidovre
Glostrup University Hospital, Copenhagen
The Danish Medical Research Council
Copenhagen Hospital Corporation
University of Copenhagen
AstraZeneca
Information provided by (Responsible Party):
Birte Glenthoj, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00207064
First received: September 10, 2005
Last updated: September 16, 2011
Last verified: September 2011
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 5-HT2A receptor binding and occupancy (PET) [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]
  • Structural MRI [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]
  • Functional MRI [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]
  • Information procession as measured with psychophysiological methods (P300, PPI, P50 gating ect.) [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]
  • An extensive battery of neurocognitive measures [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: quetiapine
flexible doses according to the clinical condition

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark, DK-2100
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600
Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Birte Glenthoj
Rigshospitalet, Denmark
Copenhagen University Hospital, Hvidovre
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:
No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Birte Glenthoj, Professor of Psychopharmacology and Neuropsychiatry, Danish Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00207064     History of Changes
Other Study ID Numbers: 363055, H-KF-01-078/97
Study First Received: September 10, 2005
Last Updated: September 16, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by University of Copenhagen:
first-episode
altanserin
5-HT2A receptors
MRI
fMRI
PPI
P300
P50 gating
endophenotypes
vulnerability indicators
quetiapine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014