Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

NCT ID: NCT00837707

Last Updated: 2009-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyskinesia, Drug-Induced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aripiprazole

Flexible dose: 5-30 mg/day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abilify

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Department of Health

AMBIG

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Taoyuan Mental Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chia-Hsiang Chan, M.D.

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taoyuan Mental Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chia-Hsiang Chan, M.D.

Role: CONTACT

886-3-3698553 ext. 2069

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chia-Hsiang Chan, M.D.

Role: primary

886-3-3698553 ext. 2069

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18433967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17614184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15830835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16219895 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMH-97-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Aripiprazole Oral Acceptability Trial
NCT00101569 COMPLETED PHASE3