SchizophreniaNCT00569764
Effect on Metabolic Parameters of Abilify in SPR
An observational study of Schizophrenia and Metabolic Syndrome, run by Seoul National Hospital at 2 sites in South Korea.
Trial summary
To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2007to Oct 2009
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with schizophrenia who want to change an antipsychotics due to metabolic side effects
Who may be able to join
- DSM-IV diagnosis with schizophrenia
- who signed an informed consent
Who cannot join
- comorbid with substance abuse or substance dependence
- pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National Hospital
Seoul, 039-757
Shi Hyun Kang, M.D., 82-2-2204-0326, drshe@hanmail.net
Jong il Lee, M.D.
- Recruiting
Seoul National Hospital
Seoul, 139-757
Jong-il Lee, M.D., Ph.D., 82-2-2204-0104, lji7542@hanmail.net
About this study
Official title: The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia
To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole
Read the detailed description
To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia.
The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- schizophrenia, metabolic syndrome, aripiprazole
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational | patients with schizophrenia who want to change an antipsychotics due to metabolic side effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose
Measured: 1 year
Secondary outcomes (1)
prolactin ECG
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startDec 2007
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National Hospital
- Sponsor type
- Other government
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Jong-il Lee, M.D., Study director, Seoul National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569764
- Sponsor's protocol ID
- snh002
- Other IDs
- MSABLI
- Status last verified
- Jun 2009
- First submitted
- 6 Dec 2007
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00569764
- Acronym / sponsor ID
- snh002
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- schizophrenia, metabolic syndrome, aripiprazole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National HospitalOther government
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2007
- Study completion
- Oct 2009 (estimated)
- First posted
- 7 Dec 2007 (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.
To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole
Detailed description
To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia.
The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | –patients with schizophrenia who want to change an antipsychotics due to metabolic side effect |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with schizophrenia who want to change an antipsychotics due to metabolic side effects
Key inclusion criteria (2 listed)
- DSM-IV diagnosis with schizophrenia
- who signed an informed consent
Key exclusion criteria (2 listed)
- comorbid with substance abuse or substance dependence
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose
Time frame: 1 year
1 secondary outcome
prolactin ECG
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
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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.
Jong-il Lee, M.D. study director
Seoul National Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Metabolic Syndrome, run by Seoul National Hospital at 2 sites in South Korea.
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 2 inclusion and 2 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 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Hyun Kang, MD (82-2-2204-0326, drshe@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose (time frame: 1 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 12 Jun 2009.