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

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ClinicalTrials.gov Identifier: NCT00197483
Recruitment Status : Suspended
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Negative Symptoms Cognitive Impairments Drug: Pergolide (drug) Phase 2

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

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 Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 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