Neuroleptic-Induced Tardive DyskinesiaPhase 4NCT00621998
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
A Phase 4 study testing risperidone and olanzapine in people with Neuroleptic-Induced Tardive Dyskinesia, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan at 1 site in Taiwan.
Trial summary
We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuroleptic-Induced Tardive Dyskinesia
- What is being tested?
- risperidone and olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2000to Jun 2004
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-70 y/o
- Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age
- Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
- Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 of ESRS)
- Patients or legal responsible people agree to join study and sign informed consent
Who cannot join
- Had other axis I diagnosis of DSM-IV
- 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.
About this study
Official title: A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.
Read the detailed description
Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia.
Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.
- Conditions
- Neuroleptic-Induced Tardive Dyskinesia
- Being tested
- risperidone, olanzapine
- Keywords
- Risperidone, Olanzapine, Tardive dyskinesia
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
0.5-6 mg/day
olanzapineDrug
2.5-20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Flexible dose of olanzapine Receives: Drug: olanzapine |
| 2 | Active comparator | Flexible dose of risperidone Receives: Drug: risperidone |
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 BPRS
Measured: The change from baseline to study endpoint
Extrapyramidal syndrome rating scale
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 posted22 Feb 2008 (estimated)
- Study startJul 2000
- Primary completionDec 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroleptic-Induced Tardive DyskinesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- Hung-Yu Chan, M.D., M.S., Study chair, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621998
- Sponsor's protocol ID
- TMH-91-02
- Other IDs
- DOH-890010
- Status last verified
- Feb 2000
- First submitted
- 13 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan HY, Chiang SC, Chang CJ, Gau SS, Chen JJ, Chen CH, Hwu HG, Lai MS. A randomized controlled trial of risperidone and olanzapine for schizophrenic patients with neuroleptic-induced tardive dyskinesia. J Clin Psychiatry. 2010 Sep;71(9):1226-33. doi: 10.4088/jcp.09m05155yel.
PubMed 20441726
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
- ClinicalTrials.gov ID
- NCT00621998
- Acronym / sponsor ID
- TMH-91-02
- Conditions
- Neuroleptic-Induced Tardive Dyskinesia
- Keywords
- Risperidone, Olanzapine, Tardive dyskinesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanOther government
- Collaborators
- Department of Health
- Study start
- Jul 2000
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 22 Feb 2008 (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.
We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.
Detailed description
Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia.
Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olanzapineFlexible dose of olanzapine |
| 2 | Active comparator | Drug: risperidoneFlexible dose of risperidone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18-70 y/o
- Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age
- Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
- Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 of ESRS)
- Patients or legal responsible people agree to join study and sign informed consent
Key exclusion criteria (4 listed)
- Had other axis I diagnosis of DSM-IV
- 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 |
|---|---|---|
| risperidone0.5-6 mg/day | Drug | 2 |
| olanzapine2.5-20 mg/day | Drug | 1 |
Primary outcome
Total scores of AIMS
Time frame: The change from baseline to study endpoint
2 secondary outcomes
Total scores of BPRS
Time frame: The change from baseline to study endpoint
Extrapyramidal syndrome rating scale
Time frame: The change from baseline to study endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
- Derived from this study: PubMed 20441726Chan HY, Chiang SC, Chang CJ, Gau SS, Chen JJ, Chen CH, Hwu HG, Lai MS. A randomized controlled trial of risperidone and olanzapine for schizophrenic patients with neuroleptic-induced tardive dyskinesia. J Clin Psychiatry. 2010 Sep;71(9):1226-33. doi: 10.4088/jcp.09m05155yel.
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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.
Hung-Yu Chan, M.D., M.S. 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 risperidone and olanzapine in people with Neuroleptic-Induced Tardive Dyskinesia, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT00621998, which also lists 1 linked publication.
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 22 Feb 2008.