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

NCT00392197 | Completed Phase 4 Results

• 2 other identifiers: 031-05-002-CJapicCTI-060325
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Schizophrenia

Keywords

OPC-14597; Schizophrenia

Outcome Measures

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.

  Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation

Secondary Outcomes (1)

• HbA1c

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

Interventions

Aripiprazole DRUG

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

Also known as: Abilify

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Touhoku Region, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 25, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2013-12

Locations

JP (5)