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

NCT00197483 | Suspended

• 1 other identifier: 01T-080
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Negative Symptoms; Cognitive Impairments

Keywords

Pergolide; Dopamine D1; Schizophrenia; Cognitive disturbance; Negative symptoms

Interventions

Pergolide (drug) DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Had a history of medical condition or drug treatment that may have affected cognitive performance
• Had a history of other psychiatric disorders

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Related Publications (4)

• 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.

  PMID: 12667537 BACKGROUND

• 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.

  PMID: 9502829 BACKGROUND

• 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.

  PMID: 14764884 BACKGROUND

• 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.

  PMID: 15118803 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction; Cognition Disorders

Interventions

Pergolide; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Norio Mori, Ph.D

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2003
• Last Updated: September 20, 2005

Record last verified: 2005-09

Locations

JP (1)