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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197483
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hamamatsu University
  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:


Further study details as provided by Hamamatsu University:

Estimated Enrollment: 20
Study Start Date: March 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs