NCT00837707

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

February 4, 2009

Last Update Submit

February 4, 2009

Conditions

Dyskinesia, Drug-Induced

Keywords

aripiprazoleTardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • Total scores of AIMS

    The change from baseline to study endpoint

Secondary Outcomes (2)

  • Total scores of PANSS

    The change from baseline to study endpoint

  • Total scores of SAS

    The change from baseline to study endpoint

Interventions

aripiprazoleDRUG

Flexible dose: 5-30 mg/day

Also known as: Abilify

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Mental Hospital

Taoyuan District, 330, Taiwan

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18433967BACKGROUND

  • 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.

    PMID: 17614184BACKGROUND

  • 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.

    PMID: 15830835BACKGROUND

  • 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.

    PMID: 16219895BACKGROUND

MeSH Terms

Conditions

Dyskinesia, Drug-InducedTardive Dyskinesia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chia-Hsiang Chan, M.D.

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

    STUDY CHAIR

Central Study Contacts

Chia-Hsiang Chan, M.D.

CONTACT

886-3-3698553cscott1125@typc.doh.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

TW(1)