Tardive Dyskinesia and Cognitive Function

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Brief Title

Tardive Dyskinesia and Cognitive Function

Official Title

Tardive Dyskinesia and Cognitive Function

Brief Summary

      Previous researchers indicate that impaired cognitive flexibility was the primary factor
      distinguishing patients with from those without tardive dyskinesia (TD)1, and cognitive
      dysfunction correlates positively with the severity of TD2. Longitudinal data raised the
      possibility that the association between cognitive dysfunction and TD may reflect not organic
      vulnerability to but rather a state marker for this movement disorder as "tardive dementia"3.
      Atypical antipsychotic had been reported to alleviate the severity of TD4 and improved
      neurocognitive function separately5. But no researchers ever investigated the correlation of
      the two effects simultaneously. This randomized, single-blind and controlled study compared
      the effect of atypical antipsychotic on TD, neurocognitive function and associated factors
      for these changes.
    

Detailed Description

      Eighty chronic schizophrenia inpatients who received conventional antipsychotics for more
      than one year, and met Schooler and Kane's criteria for persistent TD were enrolled in the
      study. The subjects were randomized to three groups: the olanzapine, amisulpride and FGA
      (first generation antipsychotic) controlled groups. Neurocognitive function were assessed
      using Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT) at baseline,
      12th week and 24th week. Clinical successive ratings were performed with Brief psychiatric
      Rating Scale (BPRS), AIMS (Abnormal Involuntary Movement Rating Scale), Simpson-Angus Rating
      Scale (SAS), Udvalg for Kliniske Undersogelser side effect ratings (UKU) and Barnes akathesia
      scale (BAS).To evaluate the influences of prognostic factors on tardive dyskinesia and
      neurocognitive function and to control for all potential confounding variables, longitudinal
      analyses on the repeated measures data were conducted using generalized estimating equation
      models (GEE).
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT)

Secondary Outcome

 Brief psychiatric Rating Scale (BPRS), Simpson-Angus Rating Scale (SAS), Udvalg for Kliniske Undersogelser side effect ratings (UKU) and Barnes akathesia scale (BAS).body weight, porlactin, metabolic components

Condition

Tardive Dyskinesia

Intervention

amisulpride

Study Arms / Comparison Groups

 Olanzapine group
Description:  randomized to Olanzapine group with dose range of 2.5-30mg/day

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

January 2003

Completion Date

December 2007

Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  schizophrenia inpatients who received conventional antipsychotics for more than one
             year,

          -  those who met Schooler and Kane's criteria for persistent TD.

        Exclusion Criteria:

          -  mental retardation,

          -  organic mental disorder,

          -  pregnancy and allergy to trial drugs.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ya Mei Bai, M.D.,Ph.D., , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT00926965

Organization ID

TD

Secondary IDs

TD


Study Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

 National Science Council, Taiwan

Study Sponsor

Ya Mei Bai, M.D.,Ph.D., Principal Investigator, Taipei Veterans General Hospital, Taipei, Taiwan


Verification Date

June 2009