Dopaminergic, Functional, Structural, and Cognitive Disturbances in First-episode Schizophrenia

NCT00206960 | Completed

• 4 other identifiers: 363002KF 01-078/97KF 01-012/98KF 11-057/99
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 6

Brief Summary

We wanted to compare dopamine D2 receptor activity, brain structure, brain function, sensory gating and cognition in neuroleptic-naive schizophrenic patients and matched healthy controls. Additionally, we wanted to examine the effects of 3 months of treatment with either low doses of a typical or an atypical antipsychotic compound on the same functions. The hypotheses were that schizophrenic patients suffered from disturbances in brain function and structure, information processing, and extrastriatal D2 receptor activity, and that these disturbances would be related to each other and to psychopathology. Additionally, we expected the atypical compound to have an effect on some of the disturbances in information processing, and that the atypical compound - in contrast to the typical drug - would show extrastriatal over striatal selectivity.

Conditions

Schizophrenia

Keywords

drug-naive; epidepride; single tomography; D2 receptor; information processing; PPI; antipsychotic treatment; MRI; fMRI; cognitive disturbances

Outcome Measures

Primary Outcomes (9)

• All examinations are done at baseline (patients and controls). In the patient group, they are repeated after 3 months of treatment

  prospective

• PANSS

  prospective

• SANS

  prospective

• SAPS

  prospective

• MRI

  prospective

• fMRI

  prospective

• startle response

  prospective

• PrePulse Inhibition of the startle response (PPI)

  prospective

• Cognition

  prospective

Secondary Outcomes (1)

• The cognitive test battery comprised tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB) as well as paper-and-pencil cognitive tests.

  prospective

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: zuclopenthixol

2

ACTIVE COMPARATOR

Drug: risperidone

Interventions

zuclopenthixol DRUG

Patients will be administered zuclopenthixol orally in doses between 4 -24 mg/day, depending on an effective reduction of symptoms

Also known as: Cisordinol

1

risperidone DRUG

Patients will be administered risperidone orally in doses between 1-6 mg/day, depending on an effective reduction of symptoms

Also known as: Risperdal

2

Eligibility Criteria

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

You may qualify if:

• For patients: Clinical diagnosis of schizophrenia.
• The controls were matched to the patients.

You may not qualify if:

• Patients: Previous antipsychotic treatment, patients who were compulsorily hospitalised or deemed in acute need of medication, mental retardation
• Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives, drug abuse, mental retardation

Sponsors & Collaborators

• Birte Glenthoj: lead
• University of Copenhagen: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Hvidovre University Hospital: collaborator
• The Danish Medical Research Council: collaborator
• Copenhagen Hospital Corporation: collaborator
• Janssen-Cilag Ltd.: collaborator
• The Novo Nordic Foundation: collaborator

Study Sites (6)

Neurobiology Research Unit, University of Copenhagen, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Dept. of Nuclear Medicine, University of Copenhagen, Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

Location

University of Copenhagen, Dept. F, Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

Location

University of Copenhagen, Dept. of Psychiatry E, Bispebjerg Hospital

Copenhagen NV, DK-2400, 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 (2)

• Mackeprang T, Kristiansen KT, Glenthoj BY. Effects of antipsychotics on prepulse inhibition of the startle response in drug-naive schizophrenic patients. Biol Psychiatry. 2002 Nov 1;52(9):863-73. doi: 10.1016/s0006-3223(02)01409-9.

  PMID: 12399139 RESULT

• Fagerlund B, Mackeprang T, Gade A, Glenthoj BY. Effects of low-dose risperidone and low-dose zuclopenthixol on cognitive functions in first-episode drug-naive schizophrenic patients. CNS Spectr. 2004 May;9(5):364-74. doi: 10.1017/s1092852900009354.

  PMID: 15115949 RESULT

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Clopenthixol; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Thioxanthenes; Sulfur Compounds; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Birte Glenthoj, MD, DMSc

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: January 1, 1998
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

DK (6)