SchizophreniaPhase 4NCT00392197

Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-

A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Schizophrenia
What is being tested?: Aripiprazole
How many people: 111 participants
Where: 5 sitesJapan
Study dates: Nov 2006to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or Female patients who are 16 years or older when written informed consent was obtained.
Patients who give personal written informed consent to participate in this study.
Patients who meet any of the following criteria for antipsychotic-naive or currently antipsychotic-free patients or patients who have been treated with antipsychotics indicated for schizophrenia from the onset of schizophrenia until the time of giving informed consent.
Antipsychotic-naive or currently antipsychotic-free patients
Patients who do not take any antipsychotics
Patients who have taken antipsychotics for less than 2 years and discontinued them for 12 weeks prior to giving informed consent

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Patients recently treated with antipsychotics
Patients who have taken antipsychotics for more than 2 years and are taking antipsychotics at the time of giving informed consent
Patients who meet all of the following conditions
Patients who do not have any obvious complication of diabetes mellitus
Patients who do not have any obvious medial history with antidiabetic agents
Patients with no obvious history of diabetes mellitus recorded in the current charts of the study site at the time of giving informed consent
Patients who have not shown any values for the following parameters that deviate from the standard laboratory values in the current charts of the study site at the time of giving informed consent
Patients whose laboratory values meet all of the following criteria in the clinical laboratory tests conducted after patients give informed consent, just before commencement of study drug administration.
Fasting blood glucose level (FBS) <110mg/dL (If FBS is not available, non-fasting blood glucose level*1 <140mg/dL)
1 : For cases in which blood sugar measurements include values that cannot be judged as having been obtained in the fasted state.
HbA1c <5.8% Fasting blood glucose is defined as glucose concentrations in plasma samples taken between 5 a.m. and 12 noon after at least eight hours of fasting (including abstinence from snacks and calorie-containing juice, coffee, etc. ). All other blood glucose measurements of are counted random glucose.
Patients who have no obvious family history (in parents or siblings) of diabetes mellitus at the time of commencement of study drug administration
Patients whose body mass index (BMI) is less than 25 kg/m2 in the current charts of the study site at the time of giving informed consent Body Mass Index (BMI) = Body weight in kg /(height in m)2

Who cannot join

Patients who have been given aripiprazole after market launching
Patients who clearly experienced symptoms of polydipsia, including so-called PET-bottle syndrome (hyperglycemia caused when the supply of insulin, which promotes glucose metabolism, becomes insufficient due to continuous soft drink consumption) and water intoxication, within one year prior to giving informed consent
Patients taking drugs that affect glucose metabolism
Patients who take quetiapine fumarate (Seroquel) or olanzapine (Zyprexia) within a period from 12 weeks prior to commencement of study drug administration to immediately before commencement of study drug administration
Patients with the following complications Abnormal adrenal function, abnormal pituitary function, abnormal thyroid function, chronic pancreatitis, chronic hepatitis, alcoholic hepatopathy, non-alcoholic fatty liver, and liver cirrhosis
Female patients who are known to have given birth to a macrosomatic infant exceeding 4000 g in weight

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Patients given antipsychotics at doses equivalent to 20 mg/day or more of haloperidol (or, in the case of multi-drug therapy, a combined equivalence of 20 mg/day or more of haloperidol) within a period from 12 weeks prior to commencement of study drug administration to immediately before commencement of study drug administration
Patients in a major state of excitation or stupor immediately before commencement of study drug administration
Patients who are forcibly hospitalized
Patients given any investigational new drugs within 12 weeks prior to commencement of study drug administration
Patients diagnosed as having a complication of serious hepatic, renal, cardiac, or haematopoietic disorder within 4 weeks prior to commencement of study drug administration, according to the criteria specified below.
Hepatic disorder: Total bilirubin ≥ 3.0 mg/dL, AST (GOT) and ALT (GPT) ≥2.5 times the upper limits of normal levels at the study site.
Renal disorder: Creatinine ≥ 2 mg/dL Heart: Congestive heart failure arrhythmias, and ischemic heart disease being treated by drug therapy Haematopoietic disorder, etc.: RBC < 3,000,000, Hb <10.0 g/dL, WBC < 3,000, platelet counts < 7,500
Pregnant or lactating women, women shown to be possibly pregnant by the pregnancy examination conducted immediately before commencement of study drug administration, and women who are hoping to become pregnant within one year after providing informed consent to participate in the study
Patients who meet any of the criteria for contraindication listed on the package insert of aripiprazole
Patients with a complication or history of neuroleptic malignant syndrome or a related condition
Patients suffering physical exhaustion associated with dehydration or malnutrition, etc.
Patients with a complication or history of paralytic ileus
Patients with a history of alcohol dependence or drug abuse
Patients with a history of suicide attempt, or patients who have a high possibility of committing self-injury or attempting suicide
Patients with a complication or history of convulsion disorders, such as epilepsy, or structural brain disorders
Patients considered in the judgment of the principal investigator or the attending investigator to be inappropriate for inclusion in the study for any other reason

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Touhoku Region

Other trials in Japan

About this study

Official title: Post Marketing Clinical Study of Aripiprazole in Patients With Schizophrenia - Effects on Glucose Metabolism-

The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.

Conditions: Schizophrenia
Being tested: Aripiprazole
Keywords: OPC-14597, Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AripiprazoleDrug
Also called Abilify
1 or 2 times a day, p.o., 6 - 24mg a day

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.
Measured: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

Secondary outcomes (1)

HbA1c
The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way
Measured: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Mar 2010

First posted25 Oct 2006 (estimated)
Study startNov 2006
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00392197
Sponsor's protocol ID: 031-05-002-C
Other IDs: JapicCTI-060325
Status last verified: Dec 2013
First submitted: 24 Oct 2006
Last updated: 12 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Clinical Study of Aripiprazole in Patients With Schizophrenia - Effects on Glucose Metabolism-
ClinicalTrials.gov ID: NCT00392197
Acronym / sponsor ID: 031-05-002-C
Conditions: Schizophrenia
Keywords: OPC-14597, Schizophrenia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 25 Oct 2006 (estimated)
Results: Posted 12 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (19 listed)

Male or Female patients who are 16 years or older when written informed consent was obtained.
Patients who give personal written informed consent to participate in this study.
Patients who meet any of the following criteria for antipsychotic-naive or currently antipsychotic-free patients or patients who have been treated with antipsychotics indicated for schizophrenia from the onset of schizophrenia until the time of giving informed consent.
Antipsychotic-naive or currently antipsychotic-free patients
Patients recently treated with antipsychotics

Key exclusion criteria (22 listed)

Patients who have been given aripiprazole after market launching
Patients who clearly experienced symptoms of polydipsia, including so-called PET-bottle syndrome (hyperglycemia caused when the supply of insulin, which promotes glucose metabolism, becomes insufficient due to continuous soft drink consumption) and water intoxication, within one year prior to giving informed consent
Patients taking drugs that affect glucose metabolism
Patients who take quetiapine fumarate (Seroquel) or olanzapine (Zyprexia) within a period from 12 weeks prior to commencement of study drug administration to immediately before commencement of study drug administration
Patients with the following complications Abnormal adrenal function, abnormal pituitary function, abnormal thyroid function, chronic pancreatitis, chronic hepatitis, alcoholic hepatopathy, non-alcoholic fatty liver, and liver cirrhosis

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: Abilify1 or 2 times a day, p.o., 6 - 24mg a day	Drug	–

Primary outcome

Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
Time frame: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation
The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.

1 secondary outcome

HbA1c
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

Results and safety

Results posted to the registry on 12 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Antipsychotic-naïve Patients	48	27
Patients Previously Treated With Antipsychotic Drugs	63	33

Primary outcome: Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)

Time frame: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation. Number. Unit: participants

Measure	Antipsychotic-naïve Patients n = 43	Patients Previously Treated With Antipsychotic Drugs n = 58
FBS: 126 mg/dL or above	0	0
FBS: 110 mg/dL or above	1	4
non-FBS: 200 mg/dL or above	0	0
non-FBS: 140 mg/dL or above	0	1

Population analysed: Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antipsychotic-naïve Patients	4 of 48 (8.3%)	45 of 48 (93.8%)	Not reported
Patients Previously Treated With Antipsychotic Drugs	6 of 63 (9.5%)	55 of 63 (87.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Katsuhisa Saito study director

Department of Clinical Research and Development, Division of New Product Evaluation and Development

5 sites 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 Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

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 19 inclusion and 22 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level) (time frame: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation). 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 NCT00392197.

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 Feb 2014.