Tardive Dyskinesia and Cognitive Function
TD
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedJune 24, 2009
June 1, 2009
4.9 years
March 2, 2008
June 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT)
24 months
Secondary Outcomes (1)
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
24 months
Study Arms (3)
Olanzapine group
EXPERIMENTALrandomized to Olanzapine group with dose range of 2.5-30mg/day
Amisulpiride group
EXPERIMENTALthe subjects were randomized to the amisulpiride group with dose range of 100 to 800mg/day
FGA group
ACTIVE COMPARATORThe subjects were randomized to maintain the conventional antipsychotics
Interventions
amisulpride tablet 100-1200mg/day for 24 months
Olanzapine tablet 2.5 to 30 mg/day for 24 months
the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics
Eligibility Criteria
You may qualify if:
- schizophrenia inpatients who received conventional antipsychotics for more than one year,
- those who met Schooler and Kane's criteria for persistent TD.
You may not qualify if:
- mental retardation,
- organic mental disorder,
- pregnancy and allergy to trial drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yu-Li Veternas Hospital
Hualien City, 981, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ya Mei Bai, M.D.,Ph.D.
Taipei Veterans General Hospital, Taipei, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 2, 2008
First Posted
June 24, 2009
Study Start
January 1, 2003
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 24, 2009
Record last verified: 2009-06