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Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT00837707
Recruitment Status : Unknown
Verified February 2009 by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan.
Recruitment status was:  Recruiting
First Posted : February 5, 2009
Last Update Posted : February 5, 2009
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Tracking Information
First Submitted Date  ICMJE February 4, 2009
First Posted Date  ICMJE February 5, 2009
Last Update Posted Date February 5, 2009
Study Start Date  ICMJE June 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
  • Total scores of PANSS [ Time Frame: The change from baseline to study endpoint ]
  • Total scores of SAS [ Time Frame: The change from baseline to study endpoint ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia
Official Title  ICMJE Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyskinesia, Drug-Induced
Intervention  ICMJE Drug: aripiprazole
Flexible dose: 5-30 mg/day
Other Name: Abilify
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2009)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2010
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00837707
Other Study ID Numbers  ICMJE TMH-97-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chia-Hsiang Chan/ Attending Psychiatrist of General Psychiatry, Taoyuan Mental Hospital
Study Sponsor  ICMJE Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Collaborators  ICMJE Department of Health
Investigators  ICMJE
Study Chair: Chia-Hsiang Chan, M.D. Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
PRS Account Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Verification Date February 2009

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