Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia - Full Text View

Sponsored by:	Hamamatsu University
Information provided by:	Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00197483

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Negative Symptoms Cognitive Impairments	Drug: Pergolide (drug)	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Dopamine Dopamine hydrochloride Pergolide Pergolide mesylate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Prospective Study
Official Title:	Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia

Further study details as provided by Hamamatsu University:

Estimated Enrollment:	20
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197483

Locations

Japan, Shizuoka
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Norio Mori, Ph.D

Hamamatsu University, School of Medicine, Department of Psychiatry and Neurology

More Information

Publications:

Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7.

Muller 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.

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.

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.

Study ID Numbers:	01T-080
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00197483
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:

Pergolide
Dopamine D1
Schizophrenia
Cognitive disturbance
Negative symptoms

Study placed in the following topic categories:

Schizophrenia
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Risperidone
Psychotic Disorders

Dementia
Pergolide
Schizophrenia and Disorders with Psychotic Features
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009