Trial Outcomes & Findings for Diabetes in Neuropsychiatric Disorders (NCT NCT00446992)
NCT ID: NCT00446992
Last Updated: 2014-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 4 week intervals
Results posted on
2014-11-19
Participant Flow
Hospital Clinic of Barcelona
Participant milestones
| Measure |
Antipsychotic-Naive Patients
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Antipsychotic-Naive Patients
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Overall Study
Adverse Event
|
11
|
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Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Diabetes in Neuropsychiatric Disorders
Baseline characteristics by cohort
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Age, Continuous
|
27.5 years
STANDARD_DEVIATION 7.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
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Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
30 participants
n=93 Participants
|
|
Socioeconomic Status (SES)
|
4.9 units on a scale
STANDARD_DEVIATION 1.6 • n=93 Participants
|
|
Body Mass Index
|
22.1 kg/m^2
STANDARD_DEVIATION 3.0 • n=93 Participants
|
|
Number of Cigarettes Per Day
|
8.1 cigarettes per day
STANDARD_DEVIATION 9.7 • n=93 Participants
|
|
Duration of Untreated Psychosis
|
1.5 Months
STANDARD_DEVIATION 1.4 • n=93 Participants
|
|
Fasting Glucose
|
82 mg/dL
STANDARD_DEVIATION 8 • n=93 Participants
|
|
Oral Glucose Tolerance Test (OGGT)
|
110 mg/dL
STANDARD_DEVIATION 35 • n=93 Participants
|
|
Fasting Insulin
|
9.7 mg/dL
STANDARD_DEVIATION 4.4 • n=93 Participants
|
|
Hemoglobin A1c
|
4.4 Percentage
STANDARD_DEVIATION 0.3 • n=93 Participants
|
|
Interleukin 6 (IL-6)
|
3.5 pg/mL
STANDARD_DEVIATION 7.2 • n=93 Participants
|
|
Positive and Negative Syndromes Scale (PANSS)
PANSS Positive
|
25 units on a scale
STANDARD_DEVIATION 7 • n=93 Participants
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|
Positive and Negative Syndromes Scale (PANSS)
PANSS Negative
|
23 units on a scale
STANDARD_DEVIATION 9 • n=93 Participants
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|
Positive and Negative Syndromes Scale (PANSS)
PANSS General
|
39 units on a scale
STANDARD_DEVIATION 10 • n=93 Participants
|
|
Positive and Negative Syndromes Scale (PANSS)
PANSS Total
|
87 units on a scale
STANDARD_DEVIATION 20 • n=93 Participants
|
|
C-Reactive Protein
|
.21 mg/dL
STANDARD_DEVIATION .34 • n=93 Participants
|
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Adiponectin
|
12.3 mg/dL
STANDARD_DEVIATION 5.9 • n=93 Participants
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Leptin
|
7.3 mg/dL
STANDARD_DEVIATION 10.4 • n=93 Participants
|
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Cortisol
|
18.3 mg/dL
STANDARD_DEVIATION 5.6 • n=93 Participants
|
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Total Cholesterol
|
163 mg/dL
STANDARD_DEVIATION 30 • n=93 Participants
|
|
Triglycerides
|
80 mg/dL
STANDARD_DEVIATION 26 • n=93 Participants
|
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LDL
|
97 mg/dL
STANDARD_DEVIATION 27 • n=93 Participants
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HDL
|
50 mg/dL
STANDARD_DEVIATION 14 • n=93 Participants
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Parental History of Type II Diabetes Mellitus
Yes
|
7 participants
n=93 Participants
|
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Parental History of Type II Diabetes Mellitus
No
|
23 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Body Mass Index
Baseline
|
22.1 kg/m^2
Standard Deviation 3.0
|
|
Body Mass Index
Week 4
|
23.5 kg/m^2
Standard Deviation 3.2
|
|
Body Mass Index
Week 8
|
24.2 kg/m^2
Standard Deviation 3.0
|
|
Body Mass Index
Week 12
|
24.3 kg/m^2
Standard Deviation 3.0
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Body Mass Index
Week 16
|
24.6 kg/m^2
Standard Deviation 2.7
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PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Fasting Glucose
Baseline
|
82.1 mg/dL
Standard Deviation 7.7
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Fasting Glucose
Week 4
|
83.2 mg/dL
Standard Deviation 6.8
|
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Fasting Glucose
Week 8
|
86.0 mg/dL
Standard Deviation 11.0
|
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Fasting Glucose
Week 12
|
85.3 mg/dL
Standard Deviation 11.1
|
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Fasting Glucose
Week 16
|
89.1 mg/dL
Standard Deviation 9.9
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PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Fasting Insulin
Baseline
|
9.7 mg/dL
Standard Deviation 4.4
|
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Fasting Insulin
Week 4
|
12.1 mg/dL
Standard Deviation 7.6
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Fasting Insulin
Week 8
|
10.5 mg/dL
Standard Deviation 3.2
|
|
Fasting Insulin
Week 12
|
11.1 mg/dL
Standard Deviation 3.0
|
|
Fasting Insulin
Week 16
|
10.7 mg/dL
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Hemoglobin A1c
Baseline
|
4.4 percentage
Standard Deviation .3
|
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Hemoglobin A1c
Week 4
|
4.4 percentage
Standard Deviation .2
|
|
Hemoglobin A1c
Week 8
|
4.3 percentage
Standard Deviation .3
|
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Hemoglobin A1c
Week 12
|
4.4 percentage
Standard Deviation .2
|
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Hemoglobin A1c
Week 16
|
4.3 percentage
Standard Deviation .2
|
PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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IL-6
Baseline
|
3.5 pg/mL
Standard Deviation 7.2
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|
IL-6
Week 4
|
3.9 pg/mL
Standard Deviation 10.7
|
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IL-6
Week 8
|
6.4 pg/mL
Standard Deviation 17.7
|
|
IL-6
Week 12
|
3.8 pg/mL
Standard Deviation 5.8
|
|
IL-6
Week 16
|
2.3 pg/mL
Standard Deviation 4.8
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PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Triglycerides
Baseline
|
80.1 mg/dL
Standard Deviation 26.2
|
|
Triglycerides
Week 4
|
98.73 mg/dL
Standard Deviation 40.0
|
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Triglycerides
Week 8
|
107.2 mg/dL
Standard Deviation 55.9
|
|
Triglycerides
Week 12
|
115.4 mg/dL
Standard Deviation 54.8
|
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Triglycerides
Week 16
|
113.47 mg/dL
Standard Deviation 53.6
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PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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Cholesterol Total
Week 12
|
188.1 mg/dL
Standard Deviation 32.9
|
|
Cholesterol Total
Week 16
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188.1 mg/dL
Standard Deviation 32.9
|
|
Cholesterol Total
Baseline
|
163.2 mg/dL
Standard Deviation 30.1
|
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Cholesterol Total
Week 4
|
184.9 mg/dL
Standard Deviation 33.3
|
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Cholesterol Total
Week 8
|
186.5 mg/dL
Standard Deviation 31.4
|
PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
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|---|---|
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HDL
Baseline
|
49.8 mg/dL
Standard Deviation 14.4
|
|
HDL
Week 4
|
50.1 mg/dL
Standard Deviation 14.2
|
|
HDL
Week 8
|
49.7 mg/dL
Standard Deviation 13.1
|
|
HDL
Week 12
|
49.7 mg/dL
Standard Deviation 13.8
|
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HDL
Week 16
|
48.4 mg/dL
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: Baseline and 4 week intervalsOutcome measures
| Measure |
Open Trial Group
n=30 Participants
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
|
|---|---|
|
LDL
Baseline
|
96.6 mg/dL
Standard Deviation 27.0
|
|
LDL
Week 4
|
115.07 mg/dL
Standard Deviation 29.0
|
|
LDL
Week 8
|
116.0 mg/dL
Standard Deviation 29.0
|
|
LDL
Week 12
|
116.0 mg/dL
Standard Deviation 30.0
|
|
LDL
Week 16
|
117.7 mg/dL
Standard Deviation 29.0
|
Adverse Events
Open Follow Up Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Follow Up Group
n=30 participants at risk
The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
|
|---|---|
|
Metabolism and nutrition disorders
Increased BMI
|
30.0%
9/30 • 16 weeks
|
|
Vascular disorders
Elevated LDL
|
6.7%
2/30 • 16 weeks
|
Additional Information
Dr. Brian Kirkpatrick
University of Nevada School of Medicine
Phone: 775-682-8459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place