Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Taoyuan Mental Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Mental Hospital
ClinicalTrials.gov Identifier:
NCT00837707
First received: February 4, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 4, 2009
February 4, 2009
June 2008
August 2009   (final data collection date for primary outcome measure)
Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Total scores of PANSS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
  • Total scores of SAS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia
Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyskinesia, Drug-Induced
Drug: aripiprazole
Flexible dose: 5-30 mg/day
Other Name: Abilify
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
February 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Chia-Hsiang Chan, M.D. 886-3-3698553 ext 2069 cscott1125@typc.doh.gov.tw
Taiwan
 
NCT00837707
TMH-97-03
No
Chia-Hsiang Chan/ Attending Psychiatrist of General Psychiatry, Taoyuan Mental Hospital
Taoyuan Mental Hospital
Department of Health
Study Chair: Chia-Hsiang Chan, M.D. Taoyuan Mental Hospital
Taoyuan Mental Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP