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Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

T

Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Status and phase

Unknown
Phase 4

Conditions

Dyskinesia, Drug-Induced

Treatments

Drug: aripiprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00837707
TMH-97-03

Details and patient eligibility

About

The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia

Full description

Objective:A few case reports on the use of aripiprazole in neuroleptic-induced tardive dyskinesia have demonstrated positive effects. However its effectiveness in treatment of TD was still inconclusive. The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia.

Method: Subjects with pre-existing neuroleptic-induced tardive dyskinesia were chosen from Taoyuan psychiatric center. Patients recruited would be treated with aripiprazole for cross-titration with previous antipsychotics in 8 weeks. We use AIMS, SAS, & BAS to assess the severity of TF and EPS. We record subjects' age, sex, and other factors which have influence at the treatment response. Subjects are assessed every two weeks in the first month and then monthly until six months.

Enrollment

25 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients must agree to prevent from being pregnant during trial periods
  • Meet psychotic disorder or mood disorder criteria of DSM-IV
  • Patients must have psychiatric diseases that need to use antipsychotics for a long time
  • They must meet DSM-IV research criteria for neuroleptics induce tardive dyskinesia
  • No clinical significant major systemic diseases
  • No special neurological diseases which would influence the assessment for EPS or TD
  • Mentality is better than mild mental retardation
  • Patients or .legal representatives agree to join in the research and sign informed consent.

Exclusion criteria

  • Unstable major systemic diseases
  • Had neurological disorder influenced to EPS assessment
  • Substance abuse or dependence other then coffee or tobacco within 6 months before study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Chia-Hsiang Chan, M.D.

Data sourced from clinicaltrials.gov

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