Trial Outcomes & Findings for Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism- (NCT NCT00392197)
NCT ID: NCT00392197
Last Updated: 2014-02-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
111 participants
Primary outcome timeframe
Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation
Results posted on
2014-02-12
Participant Flow
Participant milestones
| Measure |
Antipsychotic-naïve Patients
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
63
|
|
Overall Study
COMPLETED
|
27
|
33
|
|
Overall Study
NOT COMPLETED
|
21
|
30
|
Reasons for withdrawal
| Measure |
Antipsychotic-naïve Patients
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
12
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Protocol Violation
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-
Baseline characteristics by cohort
| Measure |
Antipsychotic-naïve Patients
n=43 Participants
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
n=58 Participants
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
43 participants
n=5 Participants
|
58 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuationPopulation: Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.
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.
Outcome measures
| Measure |
Antipsychotic-naïve Patients
n=43 Participants
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
n=58 Participants
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
FBS: 126 mg/dL or above
|
0 participants
|
0 participants
|
|
Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
FBS: 110 mg/dL or above
|
1 participants
|
4 participants
|
|
Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
non-FBS: 200 mg/dL or above
|
0 participants
|
0 participants
|
|
Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)
non-FBS: 140 mg/dL or above
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuationThe 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
Outcome measures
| Measure |
Antipsychotic-naïve Patients
n=43 Participants
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
n=58 Participants
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
HbA1c
6.5 % or more increase in HbA1c
|
0 participants
|
0 participants
|
|
HbA1c
5.8 % or more increase in HbA1c
|
0 participants
|
0 participants
|
Adverse Events
Antipsychotic-naïve Patients
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Patients Previously Treated With Antipsychotic Drugs
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antipsychotic-naïve Patients
n=48 participants at risk
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
n=63 participants at risk
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/48 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
General disorders
Irritability
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/48 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Intestine Carcinoma
|
0.00%
0/48 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Psychiatric Symptom
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
6.3%
4/63 • Number of events 4 • 54 weeks
|
|
Nervous system disorders
Restlessness
|
0.00%
0/48 • 54 weeks
|
1.6%
1/63 • Number of events 2 • 54 weeks
|
|
Nervous system disorders
Agitation
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Nervous system disorders
Depression
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
Other adverse events
| Measure |
Antipsychotic-naïve Patients
n=48 participants at risk
Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
|
Patients Previously Treated With Antipsychotic Drugs
n=63 participants at risk
Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
8.3%
4/48 • Number of events 5 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
22.9%
11/48 • Number of events 11 • 54 weeks
|
7.9%
5/63 • Number of events 7 • 54 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
6.3%
4/63 • Number of events 6 • 54 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
3.2%
2/63 • Number of events 2 • 54 weeks
|
|
Infections and infestations
Nasopharyngitis
|
27.1%
13/48 • Number of events 17 • 54 weeks
|
28.6%
18/63 • Number of events 21 • 54 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
8.3%
4/48 • Number of events 4 • 54 weeks
|
3.2%
2/63 • Number of events 2 • 54 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
4.2%
2/48 • Number of events 2 • 54 weeks
|
14.3%
9/63 • Number of events 10 • 54 weeks
|
|
Investigations
Blood Prolactin Decreased
|
39.6%
19/48 • Number of events 19 • 54 weeks
|
42.9%
27/63 • Number of events 27 • 54 weeks
|
|
Investigations
White Blood Cell Count Decreased
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
3.2%
2/63 • Number of events 2 • 54 weeks
|
|
Investigations
Weight Decreased
|
0.00%
0/48 • 54 weeks
|
9.5%
6/63 • Number of events 6 • 54 weeks
|
|
Investigations
Weight Increased
|
22.9%
11/48 • Number of events 11 • 54 weeks
|
11.1%
7/63 • Number of events 8 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
7.9%
5/63 • Number of events 5 • 54 weeks
|
|
Nervous system disorders
Akathisia
|
33.3%
16/48 • Number of events 17 • 54 weeks
|
6.3%
4/63 • Number of events 5 • 54 weeks
|
|
Nervous system disorders
Dizziness
|
8.3%
4/48 • Number of events 4 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Nervous system disorders
Dystonia
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Nervous system disorders
Headache
|
8.3%
4/48 • Number of events 4 • 54 weeks
|
11.1%
7/63 • Number of events 7 • 54 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Parkinsonism
|
10.4%
5/48 • Number of events 5 • 54 weeks
|
1.6%
1/63 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Somnolence
|
18.8%
9/48 • Number of events 9 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
Psychiatric disorders
Insomnia
|
4.2%
2/48 • Number of events 2 • 54 weeks
|
20.6%
13/63 • Number of events 14 • 54 weeks
|
|
Psychiatric disorders
Psychiatric Symptom
|
2.1%
1/48 • Number of events 1 • 54 weeks
|
6.3%
4/63 • Number of events 4 • 54 weeks
|
|
Psychiatric disorders
Restlessness
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
1.6%
1/63 • Number of events 2 • 54 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
1.6%
1/63 • Number of events 2 • 54 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
8.3%
4/48 • Number of events 5 • 54 weeks
|
0.00%
0/63 • 54 weeks
|
|
General disorders
Malaise
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
4.8%
3/63 • Number of events 3 • 54 weeks
|
|
General disorders
Thirst
|
6.2%
3/48 • Number of events 3 • 54 weeks
|
3.2%
2/63 • Number of events 2 • 54 weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place