Diabetes in Neuropsychiatric Disorders

Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446992

Enrollment

Registered

2007-03-13

Start date

2006-04-30

Completion date

2010-03-31

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Schizoaffective, psychosis, olanzapine

Brief summary

The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis. We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Detailed description

Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Interventions

DRUGOlanzapine

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Age 18-64 * Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study * No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease), * Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics) * No history of cocaine use in the previous 30 days, and * No laboratory evidence of diabetes at baseline (fasting glucose \<126 mg/dL or 2-hour glucose \<200 mg/dL on a glucose tolerance test)

Design outcomes

Primary

Measure	Time frame
IL-6	Baseline and 4 week intervals
Triglycerides	Baseline and 4 week intervals
Cholesterol Total	Baseline and 4 week intervals
Body Mass Index	Baseline and 4 week intervals
Fasting Glucose	Baseline and 4 week intervals
Fasting Insulin	Baseline and 4 week intervals
Hemoglobin A1c	Baseline and 4 week intervals
HDL	Baseline and 4 week intervals
LDL	Baseline and 4 week intervals

Countries

Spain

Participant flow

Recruitment details

Hospital Clinic of Barcelona

Participants by arm

Arm	Count
Open Trial Group 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.	30
Total	30

Arm

Count

Open Trial Group

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	11
Overall Study	Lost to Follow-up	5

Baseline characteristics

Characteristic	Open Trial Group
Adiponectin	12.3 mg/dL STANDARD_DEVIATION 5.9
Age, Continuous	27.5 years STANDARD_DEVIATION 7
Body Mass Index	22.1 kg/m^2 STANDARD_DEVIATION 3
Cortisol	18.3 mg/dL STANDARD_DEVIATION 5.6
C-Reactive Protein	.21 mg/dL STANDARD_DEVIATION 0.34
Duration of Untreated Psychosis	1.5 Months STANDARD_DEVIATION 1.4
Fasting Glucose	82 mg/dL STANDARD_DEVIATION 8
Fasting Insulin	9.7 mg/dL STANDARD_DEVIATION 4.4
HDL	50 mg/dL STANDARD_DEVIATION 14
Hemoglobin A1c	4.4 Percentage STANDARD_DEVIATION 0.3
Interleukin 6 (IL-6)	3.5 pg/mL STANDARD_DEVIATION 7.2
LDL	97 mg/dL STANDARD_DEVIATION 27
Leptin	7.3 mg/dL STANDARD_DEVIATION 10.4
Number of Cigarettes Per Day	8.1 cigarettes per day STANDARD_DEVIATION 9.7
Oral Glucose Tolerance Test (OGGT)	110 mg/dL STANDARD_DEVIATION 35
Parental History of Type II Diabetes Mellitus No	23 participants
Parental History of Type II Diabetes Mellitus Yes	7 participants
Positive and Negative Syndromes Scale (PANSS) PANSS General	39 units on a scale STANDARD_DEVIATION 10
Positive and Negative Syndromes Scale (PANSS) PANSS Negative	23 units on a scale STANDARD_DEVIATION 9
Positive and Negative Syndromes Scale (PANSS) PANSS Positive	25 units on a scale STANDARD_DEVIATION 7
Positive and Negative Syndromes Scale (PANSS) PANSS Total	87 units on a scale STANDARD_DEVIATION 20
Race/Ethnicity, Customized Other	3 participants
Race/Ethnicity, Customized White	27 participants
Region of Enrollment Spain	30 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	20 Participants
Socioeconomic Status (SES)	4.9 units on a scale STANDARD_DEVIATION 1.6
Total Cholesterol	163 mg/dL STANDARD_DEVIATION 30
Triglycerides	80 mg/dL STANDARD_DEVIATION 26

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	11 / 30
serious Total, serious adverse events	0 / 30