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CompletedNCT00392197Updated Feb 12, 2014Results posted

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

A Phase 4 interventional study of Aripiprazole in Schizophrenia, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 5 sites in Japan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-02-12.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
111
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • OPC-14597
  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 111 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or Female patients who are 16 years or older when written informed consent was obtained.
  2. Patients who give personal written informed consent to participate in this study.
  3. 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
  4. 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.
  5. Patients who have no obvious family history (in parents or siblings) of diabetes mellitus at the time of commencement of study drug administration
  6. 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

Exclusion Criteria:

  1. Patients who have been given aripiprazole after market launching
  2. 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
  3. Patients taking drugs that affect glucose metabolism
  4. 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
  5. 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
  6. Female patients who are known to have given birth to a macrosomatic infant exceeding 4000 g in weight
  7. 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
  8. Patients in a major state of excitation or stupor immediately before commencement of study drug administration
  9. Patients who are forcibly hospitalized
  10. Patients given any investigational new drugs within 12 weeks prior to commencement of study drug administration
  11. 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

  12. 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
  13. Patients who meet any of the criteria for contraindication listed on the package insert of aripiprazole
  14. Patients with a complication or history of neuroleptic malignant syndrome or a related condition
  15. Patients suffering physical exhaustion associated with dehydration or malnutrition, etc.
  16. Patients with a complication or history of paralytic ileus
  17. Patients with a history of alcohol dependence or drug abuse
  18. Patients with a history of suicide attempt, or patients who have a high possibility of committing self-injury or attempting suicide
  19. Patients with a complication or history of convulsion disorders, such as epilepsy, or structural brain disorders
  20. 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
111 participants (actual)

Interventions

  • DrugAripiprazole

    1 or 2 times a day, p.o., 6 - 24mg a day

    Also known as: Abilify

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

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

07

Results

Posted Feb 12, 2014

Participant flow

Participant flow — Overall Study
MilestoneAntipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic Drugs
Started4863
Completed2733
Not completed2130
Withdrew: Adverse event412
Withdrew: Lack of efficacy34
Withdrew: Lost to follow-up01
Withdrew: Physician decision32
Withdrew: Protocol violation75
Withdrew: Withdrawal by subject46

Outcome measures

PrimaryFasting 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.

Time frame:
Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation
Reported as:
Number · participants
Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
participantsAntipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic Drugs
FBS: 126 mg/dL or above00
FBS: 110 mg/dL or above14
non-FBS: 200 mg/dL or above00
non-FBS: 140 mg/dL or above01
SecondaryHbA1c

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

Time frame:
Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation
Reported as:
Number · participants
HbA1c
participantsAntipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic Drugs
6.5 % or more increase in HbA1c00
5.8 % or more increase in HbA1c00

Adverse events

Collected over 54 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Antipsychotic-naïve Patients—4/48 (8.3%)45/48 (93.8%)
Patients Previously Treated With Antipsychotic Drugs—6/63 (9.5%)55/63 (87.3%)
Most frequent serious events
Most frequent serious events
EventAntipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic Drugs
Psychiatric SymptomNervous system disorders1/484/63
IrritabilityGeneral disorders1/480/63
AgitationNervous system disorders1/480/63
DepressionNervous system disorders1/480/63
AstheniaGeneral disorders0/481/63
Back PainMusculoskeletal and connective tissue disorders0/481/63
Large Intestine CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/481/63
RestlessnessNervous system disorders0/481/63
Most frequent other events
Showing 10 of 28
Most frequent other events
EventAntipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic Drugs
Blood Prolactin DecreasedInvestigations19/4827/63
AkathisiaNervous system disorders16/484/63
NasopharyngitisInfections and infestations13/4818/63
ConstipationGastrointestinal disorders11/485/63
Weight IncreasedInvestigations11/487/63
InsomniaPsychiatric disorders2/4813/63
SomnolenceNervous system disorders9/480/63
Blood Creatine Phosphokinase IncreasedInvestigations2/489/63
HeadacheNervous system disorders4/487/63
ParkinsonismNervous system disorders5/481/63

Baseline characteristics

The glucose metabolism analysis set. The numbers of excluded subjects from the data of partcipant flow were: * violation of inclusion/exclusion criteria: naïve arm- 4, prior treated arm- 1 * no data of blood glucose level after treatment: naïve arm- 3, prior treated arm- 2

Age, Continuous
Age, Continuous(years)Antipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic DrugsTotal
Mean30.2 ± 13.639.9 ± 14.035.7 ± 14.6
Age, Categorical
Age, Categorical(Participants)Antipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic DrugsTotal
<=18 years606
Between 18 and 65 years365490
>=65 years145
Sex: Female, Male
Sex: Female, Male(Participants)Antipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic DrugsTotal
Female222951
Male212950
Region of Enrollment
Region of Enrollment(participants)Antipsychotic-naïve PatientsPatients Previously Treated With Antipsychotic DrugsTotal
Japan4358101
08

Study locations

5 sites
  • Hokkaido region, Japan
  • Kanto region, Japan
  • Kinki region, Japan
  • Kyushu region, Japan
  • Touhoku region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00392197
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 25, 2006
Start date
Nov 2006
Primary completion
Mar 2010
Completion
Mar 2010
Results posted
Feb 12, 2014
Last update
Feb 12, 2014

Study contacts

Katsuhisa Saito
study director · Department of Clinical Research and Development, Division of New Product Evaluation and Development
View the source record on ClinicalTrials.gov ↗

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