Viewing Study NCT00206960



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Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00206960
Status: COMPLETED
Last Update Posted: 2011-09-19
First Post: 2005-09-10

Brief Title: Dopaminergic Functional Structural and Cognitive Disturbances in First-episode Schizophrenia
Sponsor: Birte Glenthoj
Organization: University of Copenhagen

Study Overview

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
Status: COMPLETED
Status Verified Date: 2011-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: 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 treatmentThe study has resulted in two finish PhD 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 529 863-873

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 D23 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
KF 11-05799 None None None
KF 01-07897 None None None
KF 01-01298 None None None