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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00392197
First received: October 24, 2006
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Marketing Clinical Study of Aripiprazole in Patients With Schizophrenia - Effects on Glucose Metabolism-

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • HbA1c [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation ] [ Designated as safety issue: Yes ]
    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


Enrollment: 111
Study Start Date: November 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aripiprazole
    1 or 2 times a day, p.o., 6 - 24mg a day
    Other Name: Abilify
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392197

Locations
Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Touhoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Department of Clinical Research and Development, Division of New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00392197     History of Changes
Other Study ID Numbers: 031-05-002-C, JapicCTI-060325
Study First Received: October 24, 2006
Results First Received: December 19, 2013
Last Updated: December 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
OPC-14597
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014