Dyskinesia, Drug-InducedPhase 4NCT00837707
Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia
A Phase 4 study testing aripiprazole in people with Dyskinesia, Drug-Induced, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan at 1 site in Taiwan.
Trial summary
The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyskinesia, Drug-Induced
- What is being tested?
- aripiprazole
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan Mental Hospital
Taoyuan, 330
Chia-Hsiang Chan, M.D., 886-3-3698553 ext. 2069, cscott1125@typc.doh.gov.tw
Chia-Hsiang Chan, M.D.
About this study
Official title: Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia
Read the 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.
- Conditions
- Dyskinesia, Drug-Induced
- Being tested
- aripiprazole
- Keywords
- aripiprazole, Tardive Dyskinesia
- Medical subject headings
- Dyskinesia, Drug-Induced, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
Flexible dose: 5-30 mg/day
What is being measured
The primary outcome is the main question the study is designed to answer.
Total scores of AIMS
Measured: The change from baseline to study endpoint
Secondary outcomes (2)
Total scores of PANSS
Measured: The change from baseline to study endpoint
Total scores of SAS
Measured: The change from baseline to study endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2009 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dyskinesia, Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
- Sponsor type
- Other government
- Collaborators
- Department of Health
- Investigators
- Chia-Hsiang Chan, M.D., Study chair, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837707
- Sponsor's protocol ID
- TMH-97-03
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18433967Lykouras 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.
PubMed 17614184Witschy 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.
PubMed 15830835Grant 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.
PubMed 16219895
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
- ClinicalTrials.gov ID
- NCT00837707
- Acronym / sponsor ID
- TMH-97-03
- Conditions
- Dyskinesia, Drug-Induced
- Keywords
- aripiprazole, Tardive Dyskinesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanOther government
- Collaborators
- Department of Health
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aripiprazoleAlso: AbilifyFlexible dose: 5-30 mg/day | Drug | – |
Primary outcome
Total scores of AIMS
Time frame: The change from baseline to study endpoint
2 secondary outcomes
Total scores of PANSS
Time frame: The change from baseline to study endpoint
Total scores of SAS
Time frame: The change from baseline to study endpoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 18433967Aripiprazole 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.
- Background: PubMed 17614184Lykouras 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.
- Background: PubMed 15830835Witschy 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.
- Background: PubMed 16219895Grant 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.
Related trials for Dyskinesia, Drug-Induced
Not yet recruitingPhase 1
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Recruiting
rTMS as an Intervention for Levodopa-induced Dyskinesia
Dyskinesia, Drug-Induced, Parkinson Disease
Enrolling by invitation
Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hsiang Chan, M.D. study chair
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aripiprazole in people with Dyskinesia, Drug-Induced, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hsiang Chan, M.D. (886-3-3698553 ext. 2069, cscott1125@typc.doh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total scores of AIMS (time frame: The change from baseline to study endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.