Clinical trial NCT00837707: Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia
Official title: Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyskinesia, Drug-Induced
Keywords: aripiprazole
Tardive Dyskinesia
Lead sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Department of Health
First posted: 2009-02-05
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total scores of AIMS
timeFrame: The change from baseline to study endpoint
Secondary outcomes:
measure: Total scores of PANSS
timeFrame: The change from baseline to study endpoint
measure: Total scores of SAS
timeFrame: The change from baseline to study endpoint
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Mental Hospital
Study officials:
affiliation: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
name: Chia-Hsiang Chan, M.D.
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.1016/j.pnpbp.2007.06.010. Epub 2007 Jun 22. No abstract available.
citation: 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.
citation: 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.