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Completed

NCT Number: NCT00206960

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

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.

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Key information

Conditions

Schizophrenia Cognition Disorders Mental Disorders Neurocognitive 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, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark

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About this study

31 neuroleptic-naive schizophrenic patients and 25 matched controls were recruited from the greater Copenhagen area. The patients were randomized to treatment with either low doses of the typical antipsychotic compound, zuclopenthixol, or the atypical drug, risperidone. Patients and controls were examined at base-line and patients were re-examined after 3 months of treatment.The study has resulted in two finish Ph.D. theses (Torben Mackeprang and Birgitte Fagerlund).

The data has in part been published in:

Mackeprang T, Tjelle Kristiansen K, Glenthoj B. Prepulse inhibition of the startle response in drug-naïve, first-episode schizophrenic patients before and after 3 months of treatment with a typical or an atypical antipsychotic drug. Biological Psychiatry 2002; 52(9): 863-873.

and

Fagerlund B, Mackeprang T, Gade A, Hemmingsen R, Glenthoj BY. Effects of Low-Dose Risperidone and Low-Dose Zuclopenthixol on Cognitive Functions in First-Episode Drug-Naïve Schizophrenic Patients. CNS Spectr. 2004; 9: 364-74.

and

Glenthoj BY, Mackeprang T, Svarer C, Rasmussen H, Pinborg L, Friberg L, Baaré W, Hemmingsen R, Videbæk C. Frontal dopamine D2/3 receptor binding in drug-naïve first-episode schizophrenic patients correlates with positive psychotic symptoms and gender. Biological Psychiatry 2006; in press. Mar 30; [Epub ahead of print]. PMID: 16784819 [PubMed - as supplied by publisher].

We are at present conducting a five-year follow-up study of the same cohort of patients and controls and plan a ten-year follow-up as well. The follow-up studies focus on brain structure (MRI), brain function, information processing, and psychopathology. We will correlate changes in structure and function to treatment, but no interventions (pharmacological or otherwise) are planned.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Zuclopenthixol

Drug

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

Other names: Cisordinol

Risperidone

Drug

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

Other names: Risperdal

Primary outcomes

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

    Time frame: prospective

  2. PANSS

    Time frame: prospective

  3. SANS

    Time frame: prospective

  4. SAPS

    Time frame: prospective

  5. MRI

    Time frame: prospective

  6. fMRI

    Time frame: prospective

  7. startle response

    Time frame: prospective

  8. PrePulse Inhibition of the startle response (PPI)

    Time frame: prospective

  9. Cognition

    Time frame: 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.

    Time frame: prospective

Sponsors and collaborators

Lead sponsor

Birte Glenthoj

Other

Collaborators

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

Registry information

Official study title

Effects of Classical and Atypical Antipsychotics on Dopamine Receptor Binding of 123I-epidepride, Cognition, Startle Response and Extrapyramidal Side-effects in Drug-naive First-episode Schizophrenic Patients

Important dates

Study start
1998
Primary completion
2010
Study completion
2010
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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