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

NCT ID: NCT00197483

Last Updated: 2005-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Negative Symptoms Cognitive Impairments

Keywords

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Pergolide Dopamine D1 Schizophrenia Cognitive disturbance Negative symptoms

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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Pergolide (drug)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamamatsu University

OTHER

Sponsor Role lead

Principal Investigators

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Norio Mori, Ph.D

Role: STUDY_CHAIR

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

Locations

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Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Countries

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Japan

References

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Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7. doi: 10.1016/s0028-3932(02)00317-2.

Reference Type BACKGROUND
PMID: 12667537 (View on PubMed)

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. doi: 10.1523/JNEUROSCI.18-07-02720.1998.

Reference Type BACKGROUND
PMID: 9502829 (View on PubMed)

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. doi: 10.1126/science.1091162.

Reference Type BACKGROUND
PMID: 14764884 (View on PubMed)

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. doi: 10.1007/s00213-004-1793-y. Epub 2004 Apr 30.

Reference Type BACKGROUND
PMID: 15118803 (View on PubMed)

Other Identifiers

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01T-080

Identifier Type: -

Identifier Source: org_study_id