Tardive Dyskinesia and Cognitive Function

Tardive Dyskinesia Clinical Trial

— TD  

Official title:

Tardive Dyskinesia and Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926965
• Other study ID #: TD
• Secondary ID: TD
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2008
• Last updated: June 23, 2009
• Start date: January 2003
• Est. completion date: December 2007

Study information

• Verified date: June 2009
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Neurocognitive Function
• Tardive Dyskinesia

Intervention

Drug:
• amisulpride
amisulpride tablet 100-1200mg/day for 24 months
• Olanzapine
Olanzapine tablet 2.5 to 30 mg/day for 24 months
• Conventional antipsychotics
the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics

Locations

Country	Name	City	State
Taiwan	Yu-Li Veternas Hospital	Hualien

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT)		24 months	Yes
Secondary	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	Yes