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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Schizophrenia
Negative Symptoms
Cognitive Impairments

Intervention ^ICMJE

Drug: Pergolide (drug)

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00197483

Other Study ID Numbers ^ICMJE

01T-080

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hamamatsu University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Norio Mori, Ph.D

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

Information Provided By

Hamamatsu University

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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