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

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Pergolide Pergolide mesylate

U.S. FDA Resources

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 History of Changes
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:

Neurotransmitter Agents
Risperidone
Dopamine Agonists
Cognition Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine

Mental Disorders
Psychotic Disorders
Dopamine Agents
Dementia
Pergolide
Schizophrenia and Disorders with Psychotic Features
Delirium

Additional relevant MeSH terms:

Schizophrenia
Neurotransmitter Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Physiological Effects of Drugs

Dopamine Agents
Dopamine Agonists
Pergolide
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features
Cognition Disorders

ClinicalTrials.gov processed this record on September 03, 2009