Phase 4 Completed N=130 Randomized Quadruple-blind Treatment

Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

Schizophrenia · schizoaffective disorder

Source: ClinicalTrials.gov NCT00190749 ↗

Enrolled (actual)

130

Serious AEs

5.4%

Results posted

Jul 2009

Primary outcomePrimary: Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate — 0.1664; 0.1937; -0.0149; -0.0327 Mffm/I — p=0.226

Summary

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate	0.1664; 0.1937; -0.0149; -0.0327	0.226
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.	-0.212; -0.188	0.184
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)	-0.182; -0.195	0.256
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.	-0.055; 0.101	0.766
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.	0.035; 0.066	0.829
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.	0.068; 0.234	0.672
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.	0.001; -0.134	0.994
SECONDARY Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.	-0.120; 0.006	0.454
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.	0.184; 0.249	0.249
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.	-0.206; -0.263	0.201
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.	-0.048; -0.057	0.793
SECONDARY Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.	-0.043; -0.085	0.815
SECONDARY Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.	-0.137; -0.371; -0.137; -0.269; -0.009; 0.035	0.393
SECONDARY Change From Baseline to 12 Week Endpoint in Body Mass Index	28.96; 28.79; 1.02; 0.39	<.001 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Weight	85.93; 86.55; 2.98; 1.23	<.001 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Waist Circumference	99.13; 98.49; 2.38; 0.17	0.007 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Visceral Fat Area	101.46; 102.17; 4.70; 8.70	0.274
SECONDARY Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area	281.07; 317.16; 4.94; 35.15	0.406
SECONDARY Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area	0.41; 0.43; 0.01; 0.00	0.456
SECONDARY Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores	13.32; 13.96; -1.98; -1.48; 5.22; 5.27	0.111
SECONDARY Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores	3.65; 3.61; -0.22; -0.23	.012 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores	0.48; 0.53; 0.04; 0.04	0.943
SECONDARY Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores	0.24; 0.36; 0.02; -0.02	0.623
SECONDARY Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores	1.13; 0.94; -0.06; 0.30	0.302
SECONDARY Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores	1.42; 1.32; 0.25; 0.42; 1.54; 1.32	0.004 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol	4.91; 4.97; 0.18; 0.01	0.156
SECONDARY Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)	3.18; 3.11; -0.03; -0.02	0.740
SECONDARY Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)	1.08; 1.18; 0.06; 0.05	0.176
SECONDARY Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides	1.68; 1.55; 0.34; -0.10	0.027 sig
SECONDARY Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses	28.39; 29.81; 1.71; -1.09; 53.18; 52.56	0.009 sig

Eligibility Criteria

Inclusion Criteria

18-65 years old
Diagnosed with Schizophrenia or Schizoaffective disorder
Ability to visit the doctor's office for scheduled visits

Exclusion Criteria

Women who are pregnant or breastfeeding
Have a body mass index (BMI) greater than 40
Have diabetes, heart disease or any other unstable illness
Have known positive human immunodeficiency virus (HIV)
Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00190749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.