Tardive Dyskinesia and Cognitive Function (TD)
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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 |
- 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 ]
- 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 |
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| Taiwan | |
| Yu-Li Veternas Hospital | |
| Hualien, Taiwan, 981 | |
| 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 May 21, 2013