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Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

Primary Purpose

Dyskinesia, Drug-Induced

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyskinesia, Drug-Induced focused on measuring aripiprazole, Tardive Dyskinesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taoyuan Mental HospitalRecruiting

Outcomes

Primary Outcome Measures

Total scores of AIMS

Secondary Outcome Measures

Total scores of PANSS
Total scores of SAS

Full Information

First Posted
February 4, 2009
Last Updated
February 4, 2009
Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Collaborators
Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00837707
Brief Title
Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia
Official Title
Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Collaborators
Department of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyskinesia, Drug-Induced
Keywords
aripiprazole, Tardive Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Flexible dose: 5-30 mg/day
Primary Outcome Measure Information:
Title
Total scores of AIMS
Time Frame
The change from baseline to study endpoint
Secondary Outcome Measure Information:
Title
Total scores of PANSS
Time Frame
The change from baseline to study endpoint
Title
Total scores of SAS
Time Frame
The change from baseline to study endpoint

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hsiang Chan, M.D.
Phone
886-3-3698553
Ext
2069
Email
cscott1125@typc.doh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hsiang Chan, M.D.
Organizational Affiliation
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taoyuan Mental Hospital
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Hsiang Chan, M.D.
Phone
886-3-3698553
Ext
2069
Email
cscott1125@typc.doh.gov.tw
First Name & Middle Initial & Last Name & Degree
Chia-Hsiang Chan, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
18433967
Citation
Aripiprazole improves neuroleptic-associated tardive dyskinesia, but it does not meliorate psychotic symptoms. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Jul 1;32(5):1342-3. doi: 10.1016/j.pnpbp.2008.03.003. Epub 2008 Mar 18. No abstract available.
Results Reference
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PubMed Identifier
17614184
Citation
Lykouras L, Rizos E, Gournellis R. Aripiprazole in the treatment of tardive dyskinesia induced by other atypical antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1535-6. doi: 10.1016/j.pnpbp.2007.06.010. Epub 2007 Jun 22. No abstract available.
Results Reference
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PubMed Identifier
15830835
Citation
Witschy JK, Winter AS. Improvement in tardive dyskinesia with aripiprazole use. Can J Psychiatry. 2005 Mar;50(3):188. doi: 10.1177/070674370505000321. No abstract available.
Results Reference
background
PubMed Identifier
16219895
Citation
Grant MJ, Baldessarini RJ. Possible improvement of neuroleptic-associated tardive dyskinesia during treatment with aripiprazole. Ann Pharmacother. 2005 Nov;39(11):1953. doi: 10.1345/aph.1G255. Epub 2005 Oct 11. No abstract available.
Results Reference
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Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

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