Schizophrenia Clinical Trial
Official title:
Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia
NCT number | NCT00197483 |
Other study ID # | 01T-080 |
Secondary ID | |
Status | Suspended |
Phase | Phase 2 |
First received | September 13, 2005 |
Last updated | September 13, 2005 |
Start date | March 2003 |
Verified date | September 2005 |
Source | Hamamatsu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. This double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.
Status | Suspended |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: Patients - Were age 18–50 years, met the DSM-IV criteria for schizophrenia - Were treated with a stable dose of risperidone, raging 2 to 6mg, for more than 8 weeks - Had a score =15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS) - Had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks Exclusion Criteria: - Had a history of medical condition or drug treatment that may have affected cognitive performance - Had a history of other psychiatric disorders |
Observational Model: Defined Population, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Japan | Hamamatsu University Hospital | Hamamatsu | Shizuoka |
Lead Sponsor | Collaborator |
---|---|
Hamamatsu University |
Japan,
Goldman-Rakic PS, Castner SA, Svensson TH, Siever LJ, Williams GV. Targeting the dopamine D1 receptor in schizophrenia: insights for cognitive dysfunction. Psychopharmacology (Berl). 2004 Jun;174(1):3-16. Epub 2004 Apr 30. Review. — View Citation
Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7. — View Citation
Müller U, von Cramon DY, Pollmann S. D1- versus D2-receptor modulation of visuospatial working memory in humans. J Neurosci. 1998 Apr 1;18(7):2720-8. — View Citation
Wang M, Vijayraghavan S, Goldman-Rakic PS. Selective D2 receptor actions on the functional circuitry of working memory. Science. 2004 Feb 6;303(5659):853-6. — View Citation
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