Tardive Dyskinesia and Cognitive Function (TD)
Primary Purpose
Tardive Dyskinesia, Neurocognitive Function
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
amisulpride
Olanzapine
Conventional antipsychotics
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia focused on measuring tardive dyskinesia, neurocognitive function
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.
Sites / Locations
- Yu-Li Veternas Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Olanzapine group
Amisulpiride group
FGA group
Arm Description
randomized to Olanzapine group with dose range of 2.5-30mg/day
the subjects were randomized to the amisulpiride group with dose range of 100 to 800mg/day
The subjects were randomized to maintain the conventional antipsychotics
Outcomes
Primary Outcome Measures
change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00926965
First Posted
March 2, 2008
Last Updated
June 23, 2009
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00926965
Brief Title
Tardive Dyskinesia and Cognitive Function
Acronym
TD
Official Title
Tardive Dyskinesia and Cognitive Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia, Neurocognitive Function
Keywords
tardive dyskinesia, neurocognitive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine group
Arm Type
Experimental
Arm Description
randomized to Olanzapine group with dose range of 2.5-30mg/day
Arm Title
Amisulpiride group
Arm Type
Experimental
Arm Description
the subjects were randomized to the amisulpiride group with dose range of 100 to 800mg/day
Arm Title
FGA group
Arm Type
Active Comparator
Arm Description
The subjects were randomized to maintain the conventional antipsychotics
Intervention Type
Drug
Intervention Name(s)
amisulpride
Other Intervention Name(s)
solian
Intervention Description
amisulpride tablet 100-1200mg/day for 24 months
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
zyprexa
Intervention Description
Olanzapine tablet 2.5 to 30 mg/day for 24 months
Intervention Type
Drug
Intervention Name(s)
Conventional antipsychotics
Other Intervention Name(s)
conventional antipsychotic
Intervention Description
the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics
Primary Outcome Measure Information:
Title
change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya Mei Bai, M.D.,Ph.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yu-Li Veternas Hospital
City
Hualien
ZIP/Postal Code
981
Country
Taiwan
12. IPD Sharing Statement
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Tardive Dyskinesia and Cognitive Function
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