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

Sponsor

Hamamatsu University (Other)

Overall Status

Suspended

CT.gov ID

NCT00197483

Collaborator

(none)

Enrollment

Location

Study Details

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)

Study Design

Study Type:

Observational

Observational Model:

Defined Population

Time Perspective:

Other

Official Title:

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

Study Start Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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