Tardive Dyskinesia and Cognitive Function

NCT ID: NCT00926965

Last Updated: 2009-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2007-12-31

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).

Conditions

Tardive Dyskinesia; Neurocognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Olanzapine group

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

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Olanzapine tablet 2.5 to 30 mg/day for 24 months

Amisulpiride group

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

Group Type: EXPERIMENTAL

amisulpride

Intervention Type: DRUG

amisulpride tablet 100-1200mg/day for 24 months

FGA group

The subjects were randomized to maintain the conventional antipsychotics

Group Type: ACTIVE_COMPARATOR

Conventional antipsychotics

Intervention Type: DRUG

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

Interventions

amisulpride

amisulpride tablet 100-1200mg/day for 24 months

Intervention Type: DRUG

Olanzapine

Olanzapine tablet 2.5 to 30 mg/day for 24 months

Intervention Type: DRUG

Conventional antipsychotics

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

Intervention Type: DRUG

Other Intervention Names

solian; zyprexa; conventional antipsychotic

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yu-Li Veterans Hospital

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taipei, Taiwan

Locations

Yu-Li Veternas Hospital

Hualien City, , Taiwan

Countries

Taiwan

Other Identifiers

TD

Identifier Type: -

Identifier Source: secondary_id

TD

Identifier Type: -

Identifier Source: org_study_id