A double-blind, placebo-controlled trial of rosiglitazone for clozapine-induced glucose metabolism impairment in patients with schizophrenia.
The primary purpose of this 8-week double-blind, placebo-controlled trial of rosiglitazone 4 mg/day was to examine its effect on insulin sensitivity index (SI) and glucose utilization (SG) in clozapine-treated subjects with schizophrenia with insulin resistance.



Eighteen subjects were randomized and accessed with a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) at baseline and at week 8 to estimate SG and SI.



Controlling for the baseline, comparing the rosiglitazone group with placebo group, there was a non-significant improvement in SG (0.016 +/- 0.006-0.018 +/- 0.008, effect size = 0.23, P = 0.05) with a trend of improvement in SI in the rosiglitazone group (4.6 +/- 2.8-7.8 +/- 6.7, effect size = 0.18, P = 0.08). There was a significant reduction in small low-density lipoprotein cholesterol (LDL-C) particle number (987 +/- 443-694 +/- 415, effect size = 0.30, P = 0.04).



Rosiglitazone may have a role in addressing insulin resistance and lipid abnormalities associated with clozapine.
Henderson
D C
DC
Schizophrenia Program, Massachusetts General Hospital, Boston, MA, USA. dchenderson@partners.org
Fan
X
X
Sharma
B
B
Copeland
P M
PM
Borba
C P
CP
Boxill
R
R
Freudenreich
O
O
Cather
C
C
Evins
A E
AE
Goff
D C
DC
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D008078:Cholesterol, LDL / Q000378:metabolism; D003024:Clozapine / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance; D008297:Male; D024821:Metabolic Syndrome / Q000139:chemically induced* / Q000188:drug therapy; D008875:Middle Aged; D010919:Placebos; D000077154:Rosiglitazone; D012559:Schizophrenia / Q000188:drug therapy* / Q000378:metabolism; D045162:Thiazolidinediones / Q000627:therapeutic use*
D001786:Blood Glucose; D008078:Cholesterol, LDL; D007004:Hypoglycemic Agents; D010919:Placebos; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D003024:Clozapine