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
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.
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 →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
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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
Patients who meet all of the following conditions
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.
Exclusion Criteria:
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
1 or 2 times a day, p.o., 6 - 24mg a day
Also known as: Abilify
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
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
| Milestone | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs |
|---|---|---|
| Started | 48 | 63 |
| Completed | 27 | 33 |
| Not completed | 21 | 30 |
| Withdrew: Adverse event | 4 | 12 |
| Withdrew: Lack of efficacy | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Protocol violation | 7 | 5 |
| Withdrew: Withdrawal by subject | 4 | 6 |
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.
| participants | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs |
|---|---|---|
| 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 |
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
| participants | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs |
|---|---|---|
| 6.5 % or more increase in HbA1c | 0 | 0 |
| 5.8 % or more increase in HbA1c | 0 | 0 |
Collected over 54 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs |
|---|---|---|
| Psychiatric SymptomNervous system disorders | 1/48 | 4/63 |
| IrritabilityGeneral disorders | 1/48 | 0/63 |
| AgitationNervous system disorders | 1/48 | 0/63 |
| DepressionNervous system disorders | 1/48 | 0/63 |
| AstheniaGeneral disorders | 0/48 | 1/63 |
| Back PainMusculoskeletal and connective tissue disorders | 0/48 | 1/63 |
| Large Intestine CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/48 | 1/63 |
| RestlessnessNervous system disorders | 0/48 | 1/63 |
| Event | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs |
|---|---|---|
| Blood Prolactin DecreasedInvestigations | 19/48 | 27/63 |
| AkathisiaNervous system disorders | 16/48 | 4/63 |
| NasopharyngitisInfections and infestations | 13/48 | 18/63 |
| ConstipationGastrointestinal disorders | 11/48 | 5/63 |
| Weight IncreasedInvestigations | 11/48 | 7/63 |
| InsomniaPsychiatric disorders | 2/48 | 13/63 |
| SomnolenceNervous system disorders | 9/48 | 0/63 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 2/48 | 9/63 |
| HeadacheNervous system disorders | 4/48 | 7/63 |
| ParkinsonismNervous system disorders | 5/48 | 1/63 |
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(years) | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs | Total |
|---|---|---|---|
| Mean | 30.2 ± 13.6 | 39.9 ± 14.0 | 35.7 ± 14.6 |
| Age, Categorical(Participants) | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs | Total |
|---|---|---|---|
| <=18 years | 6 | 0 | 6 |
| Between 18 and 65 years | 36 | 54 | 90 |
| >=65 years | 1 | 4 | 5 |
| Sex: Female, Male(Participants) | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs | Total |
|---|---|---|---|
| Female | 22 | 29 | 51 |
| Male | 21 | 29 | 50 |
| Region of Enrollment(participants) | Antipsychotic-naïve Patients | Patients Previously Treated With Antipsychotic Drugs | Total |
|---|---|---|---|
| Japan | 43 | 58 | 101 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Co., Ltd.