Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this pilot randomized clinical trial is to begin to delineate the
pathophysiological changes associated with antipsychotic associated metabolic side effects.
The study will be performed in 36 healthy people between the ages of 18 and 30, who have
never taken an antipsychotic, will undergo baseline laboratory tests before being randomized
to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The
primary outcome measure will be a correlation of early changes in leptin with weight gain. We
will also record changes in food intake, resting metabolic rate, oral glucose tolerance and
fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be
followed closely to monitor for safety throughout the 4-week study and will be discontinued
if there is a medically significant change in metabolic status or other antipsychotic side
effects. Metabolic assessments will be performed again at the time of discontinuation or at
the end of an 4-week period, and change from baseline in the two treatment groups will be
compared.