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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197483
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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
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
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:

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

Keywords provided by Hamamatsu University:
Pergolide
Dopamine D1
Schizophrenia
Cognitive disturbance
Negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Pergolide
 Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013