Tardive Dyskinesia and Cognitive Function

Study Overview
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Brief Summary
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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 dementia3. 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
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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).

Official Title
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Tardive Dyskinesia and Cognitive Function

Conditions
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Tardive Dyskinesia, Neurocognitive Function

Intervention / Treatment
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* Drug: amisulpride
* Drug: Olanzapine
* Drug: Conventional antipsychotics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tardive dyskinesia, neurocognitive function