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NCT00197483 Clinical Trial

Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia

Schizophrenia Clinical Trial

Official title:
Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia

Clinical Trial Details — Status: Suspended

Administrative data
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

Study information
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

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Drug:
• Pergolide (drug)

Locations
Country Name City State
Japan Hamamatsu University Hospital Hamamatsu Shizuoka

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

References & Publications (4)

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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