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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
  Purpose

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


Condition Intervention Phase
Dyskinesia, Drug-Induced
 Drug: aripiprazole
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taoyuan Mental Hospital:

Primary Outcome Measures:
  • Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: June 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aripiprazole
    Flexible dose: 5-30 mg/day
    Other Name: Abilify
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837707

Contacts
Contact: Chia-Hsiang Chan, M.D. 886-3-3698553 ext 2069 cscott1125@typc.doh.gov.tw

Locations
Taiwan
Taoyuan Mental Hospital Recruiting
Taoyuan, Taiwan, 330
Contact: Chia-Hsiang Chan, M.D.     886-3-3698553 ext 2069     cscott1125@typc.doh.gov.tw    
Principal Investigator: Chia-Hsiang Chan, M.D.            
Sponsors and Collaborators
Taoyuan Mental Hospital
Department of Health
Investigators
Study Chair: Chia-Hsiang Chan, M.D. Taoyuan Mental Hospital
  More Information

Publications:

Responsible Party: Chia-Hsiang Chan/ Attending Psychiatrist of General Psychiatry, Taoyuan Mental Hospital
ClinicalTrials.gov Identifier: NCT00837707     History of Changes
Other Study ID Numbers: TMH-97-03
Study First Received: February 4, 2009
Last Updated: February 4, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taoyuan Mental Hospital:
aripiprazole
Tardive Dyskinesia

Additional relevant MeSH terms:
Dyskinesias
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug Toxicity
Poisoning
 Substance-Related Disorders
Antipsychotic Agents
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013