Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia | NCT00837707

Studies
Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

NCT00837707

Sponsor

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

Status

Unknown status

Last Update Posted

Feb 5, 2009Estimated

Enrollment

25Estimated

Phase

Phase 4

Conditions

Dyskinesia, Drug-Induced

Interventions

aripiprazole

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2009Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 4, 2009

First Posted Date

Feb 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Name	Class
Department of Health	AMBIG

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
aripiprazole	Drug	Flexible dose: 5-30 mg/day		Abilify

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total scores of AIMS		The change from baseline to study endpoint

Secondary Outcomes

Measure	Description	Time Frame
Total scores of PANSS		The change from baseline to study endpoint
Total scores of SAS		The change from baseline to study endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chia-Hsiang Chan, M.D.	Contact	886-3-3698553	2069	cscott1125@typc.doh.gov.tw

Overall Officials

Name	Affiliation	Role
Chia-Hsiang Chan, M.D.	Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taoyuan Mental Hospital	Recruiting	Taoyuan		330	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18433967	Background	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.
17614184	Background	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.

ID	Term
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

ID	Term
D004409	Dyskinesia, Drug-Induced
D000071057	Tardive Dyskinesia