TD: Tardive Dyskinesia and Cognitive Function

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT00926965

Collaborator

National Science Council, Taiwan (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tardive Dyskinesia Neurocognitive Function	Drug: amisulpride Drug: Olanzapine Drug: Conventional antipsychotics	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Tardive Dyskinesia and Cognitive Function

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine group randomized to Olanzapine group with dose range of 2.5-30mg/day	Drug: Olanzapine Olanzapine tablet 2.5 to 30 mg/day for 24 months Other Names: zyprexa
Experimental: Amisulpiride group the subjects were randomized to the amisulpiride group with dose range of 100 to 800mg/day	Drug: amisulpride amisulpride tablet 100-1200mg/day for 24 months Other Names: solian
Active Comparator: FGA group The subjects were randomized to maintain the conventional antipsychotics	Drug: Conventional antipsychotics the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics Other Names: conventional antipsychotic

Arm

Intervention/Treatment

Experimental: Olanzapine group

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

Drug: Olanzapine

Olanzapine tablet 2.5 to 30 mg/day for 24 months

Other Names:

zyprexa

Experimental: Amisulpiride group

the subjects were randomized to the amisulpiride group with dose range of 100 to 800mg/day

Drug: amisulpride

amisulpride tablet 100-1200mg/day for 24 months

Other Names:

solian

Active Comparator: FGA group

The subjects were randomized to maintain the conventional antipsychotics

Drug: Conventional antipsychotics

the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics

Other Names:

conventional antipsychotic

Outcome Measures

Primary Outcome Measures

change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT) [24 months]

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 [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

schizophrenia inpatients who received conventional antipsychotics for more than one year,
those who met Schooler and Kane's criteria for persistent TD.