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| Sponsors and Collaborators: |
Bispebjerg Hospital University of Copenhagen Glostrup University Hospital,Copenhagen Rigshospitalet, Denmark Hvidovre University Hospital The Danish Medical Research Council Copenhagen Hospital Corporation Janssen-Cilag Ltd. The Novo Nordic Foundation |
|---|---|
| Information provided by: | Bispebjerg Hospital |
| ClinicalTrials.gov Identifier: | NCT00206960 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: zuclopenthixol or risperidone |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Factorial Assignment, Pharmacodynamics Study |
| Official 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 |
| Estimated Enrollment: | 56 |
| Study Start Date: | January 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | |
| Glostrup, Denmark, DK-2600 | |
| Dept. of Nuclear Medicine, University of Copenhagen, Bispebjerg Hospital | |
| Copenhagen NV, Denmark, DK-2400 | |
| Neurobiology Research Unit, University of Copenhagen, Rigshospitalet | |
| Copenhagen, Denmark, DK-2100 | |
| University of Copenhagen, Dept. F, Bispebjerg Hospital | |
| Copenhagen NV, Denmark, DK-2400 | |
| University of Copenhagen, Dept. of Psychiatry E, Bispebjerg Hospital | |
| Copenhagen NV, Denmark, DK-2400 | |
| Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital | |
| Hvidovre, Denmark, DK-2650 | |
| Study Director: | Birte Glenthoj, MD, DMSc | University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark |
More Information
| Study ID Numbers: | 363002, KF 01-078/97, KF 01-012/98, KF 11-057/99 |
| Study First Received: | September 10, 2005 |
| Last Updated: | September 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00206960 |
| Health Authority: | Denmark: National Board of Health |
|
drug-naive epidepride single tomography D2 receptor information processing |
PPI antipsychotic treatment MRI fMRI cognitive disturbances |
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Schizophrenia Dopamine Mental Disorders Clopenthixol |
Risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
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Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |
