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Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00837707
Enrollment
25
Registered
2009-02-05
Start date
2008-06-30
Completion date
2010-02-28
Last updated
2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyskinesia, Drug-Induced

Keywords

aripiprazole, Tardive Dyskinesia

Brief summary

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

Detailed 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.

Interventions

DRUGaripiprazole

Flexible dose: 5-30 mg/day

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total scores of AIMSThe change from baseline to study endpoint

Secondary

MeasureTime frame
Total scores of PANSSThe change from baseline to study endpoint
Total scores of SASThe change from baseline to study endpoint

Countries

Taiwan

Contacts

Primary ContactChia-Hsiang Chan, M.D.
cscott1125@typc.doh.gov.tw886-3-3698553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026