Trial record 5 of 38 for:    Tardive Dyskinesia

Tardive Dyskinesia and Cognitive Function (TD)

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00926965
First received: March 2, 2008
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Tardive Dyskinesia
Neurocognitive Function
Drug: amisulpride
Drug: Olanzapine
Drug: Conventional antipsychotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Tardive Dyskinesia and Cognitive Function

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • change of Abnormal Involuntary movement scale(AIMS), Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: conventional antipsychotic

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926965

Locations
Taiwan
Yu-Li Veternas Hospital
Hualien, Taiwan, 981
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: Ya Mei Bai, M.D.,Ph.D. Taipei Veterans General Hospital, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: Yu-Li Veterans Hospital
ClinicalTrials.gov Identifier: NCT00926965     History of Changes
Other Study ID Numbers: TD, TD
Study First Received: March 2, 2008
Last Updated: June 23, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
tardive dyskinesia
neurocognitive function

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Sultopride
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014