Phase 4
Completed N=111
Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-
Source: ClinicalTrials.gov NCT00392197 ↗Enrolled (actual)
111
Serious AEs
9.0%
Results posted
Feb 2014
Primary outcomePrimary: Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level) — 0; 0; 1; 4 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level) |
0; 0; 1; 4; 0; 0 | — |
| SECONDARY HbA1c |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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
Exclusion Criteria
- 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
- 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 comm
Data sourced from ClinicalTrials.gov (NCT00392197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.