Metabolic Syndrome XNCT00956189
Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome
A study testing amisulpride and aripiprazole in people with Metabolic Syndrome X, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
The investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. The accuracy of the investigators' models showed well. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- amisulpride and aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesTaiwan
- Study dates
- Nov 2009to Oct 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on DSM-IV-TR criteria.
- Age at least 20 years old.
- The current antipsychotic drugs have been used for at least 3 months before evaluation.
- Psychiatrically stable with Clinical Global Impression of Severity scale (CGI-S) not greater than 5
- The same as Stage I criteria.
- Fulfill the metabolic syndrome criteria.
Who cannot join
- Severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases).
- Organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin).
- Pregnant or breast-feeding women.
- Patients from Yuli Veterans Hospital, who attended our previous study of identification model.
- Stage II for switch response:
- The same as Stage I criteria except the 4th item.
- Treated with depot form of antipsychotics.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Taiwan University Hospital
Taipei, 10002
Yu-Li Hospital
Yuli, Hualien County, 981
Yu-Li Veterans Hospital
Yuli, Hualien County, 981
About this study
Official title: Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
The investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the study, the investigators aim to (1) to examine whether the developed identification models can be generalized to patients taking other antipsychotics or patients with other diagnoses; (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of metabolic parameters including adiponectin, and analyze their association with genetic variants, demography, and clinical variables; (4) to establish models using artificial neural network and statistic method to predict metabolic response after a switch to amisulpride or aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression and secretion during the differentiation process of 3T3L1 adipocytes.
- Conditions
- Metabolic Syndrome X
- Being tested
- amisulpride, aripiprazole
- Keywords
- Antipsychotic Agents, Metabolic Syndrome X, Identification, Prediction
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amisulprideDrug
Also called Solian
Amisulpride dosage was increased from 200 up to a maximum of 1000 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
aripiprazoleDrug
Also called Abilify
Aripiprazole dosage was increased from 5-7.5 up to a maximum of 30 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride | Experimental | A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride. Receives: Drug: amisulpride |
| Aripiprazole | Experimental | A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole. Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic profile
Measured: half/one year
Secondary outcomes (1)
Clinical efficacy
Measured: half/one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yu-Li Veterans Hospital, Yu-Li Hospital
- Responsible party
- Sponsor
- Investigators
- Chao-Cheng Lin, M.D.,Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956189
- Sponsor's protocol ID
- 200812110M
- Status last verified
- Nov 2012
- First submitted
- 10 Aug 2009
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00956189
- Acronym / sponsor ID
- 200812110M
- Conditions
- Metabolic Syndrome X
- Keywords
- Antipsychotic Agents, Metabolic Syndrome X, Identification, Prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Yu-Li Veterans Hospital, Yu-Li Hospital
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Aug 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 investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the study, the investigators aim to (1) to examine whether the developed identification models can be generalized to patients taking other antipsychotics or patients with other diagnoses; (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of metabolic parameters including adiponectin, and analyze their association with genetic variants, demography, and clinical variables; (4) to establish models using artificial neural network and statistic method to predict metabolic response after a switch to amisulpride or aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression and secretion during the differentiation process of 3T3L1 adipocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amisulpride | Experimental | Drug: amisulprideA slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride. |
| Aripiprazole | Experimental | Drug: aripiprazoleA slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on DSM-IV-TR criteria.
- Age at least 20 years old.
- The current antipsychotic drugs have been used for at least 3 months before evaluation.
- Psychiatrically stable with Clinical Global Impression of Severity scale (CGI-S) not greater than 5
- The same as Stage I criteria.
Key exclusion criteria (7 listed)
- Severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases).
- Organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin).
- Pregnant or breast-feeding women.
- Patients from Yuli Veterans Hospital, who attended our previous study of identification model.
- The same as Stage I criteria except the 4th item.
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 |
|---|---|---|
| amisulprideAlso: SolianAmisulpride dosage was increased from 200 up to a maximum of 1000 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition. | Drug | Amisulpride |
| aripiprazoleAlso: AbilifyAripiprazole dosage was increased from 5-7.5 up to a maximum of 30 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition. | Drug | Aripiprazole |
Primary outcome
Metabolic profile
Time frame: half/one year
1 secondary outcome
Clinical efficacy
Time frame: half/one year
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 3 Jan 2013.
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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.
Chao-Cheng Lin, M.D.,Ph.D. principal investigator
National Taiwan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amisulpride and aripiprazole in people with Metabolic Syndrome X, run by National Taiwan University Hospital at 3 sites 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 6 inclusion and 7 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Metabolic profile (time frame: half/one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2013.