Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

Dyskinesia, Drug-Induced Clinical Trial

Official title:

Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00837707
• Other study ID #: TMH-97-03
• Status: Recruiting
• Phase: Phase 4
• First received: February 4, 2009
• Last updated: February 4, 2009
• Start date: June 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2009
• Source: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
• Contact: Chia-Hsiang Chan, M.D.
• Phone: 886-3-3698553
• Email: cscott1125[@]typc.doh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesias

Intervention

Drug:
• aripiprazole
Flexible dose: 5-30 mg/day

Locations

Country	Name	City	State
Taiwan	Taoyuan Mental Hospital	Taoyuan

Sponsors (2)

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

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Grant MJ, Baldessarini RJ. Possible improvement of neuroleptic-associated tardive dyskinesia during treatment with aripiprazole. Ann Pharmacother. 2005 Nov;39(11):1953. Epub 2005 Oct 11. — View Citation

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. Epub 2007 Jun 22. — View Citation

Witschy JK, Winter AS. Improvement in tardive dyskinesia with aripiprazole use. Can J Psychiatry. 2005 Mar;50(3):188. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total scores of AIMS		The change from baseline to study endpoint	No
Secondary	Total scores of PANSS		The change from baseline to study endpoint	No
Secondary	Total scores of SAS		The change from baseline to study endpoint	No