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

NCT00206960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-09-19

No results posted yet for this study

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

Interventions

DRUG

zuclopenthixol

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

DRUG

risperidone

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Glostrup University Hospital, Copenhagen

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Hvidovre University Hospital

    collaborator OTHER
  • The Danish Medical Research Council

    collaborator OTHER
  • Copenhagen Hospital Corporation

    collaborator OTHER
  • Janssen-Cilag Ltd.

    collaborator INDUSTRY
  • The Novo Nordic Foundation

    collaborator OTHER
  • Birte Glenthoj

    lead OTHER

Principal Investigators

  • Birte Glenthoj, MD, DMSc · University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00206960 on ClinicalTrials.gov