Tardive Dyskinesia and Cognitive Function (TD)

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.

Study Overview

• Status: Completed
• Conditions: Tardive Dyskinesia; Neurocognitive Function
• Intervention / Treatment: Drug: Olanzapine; Drug: amisulpride; Drug: Conventional antipsychotics

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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Hualien, Taiwan, 981
    • Yu-Li Veternas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: conventional antipsychotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Ya Mei Bai, M.D.,Ph.D., Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: March 2, 2008
• First Submitted That Met QC Criteria: June 23, 2009
• First Posted (ESTIMATE): June 24, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2009
• Last Update Submitted That Met QC Criteria: June 23, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: tardive dyskinesia; neurocognitive function
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Tardive Dyskinesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Olanzapine; Amisulpride; Antipsychotic Agents
• Other Study ID Numbers: TD