drugset / Trial / NCT00567034

Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects

NCT00567034

Phase 1 Completed 30 enrolled Mclean Hospital
RandomizedParallel-groupDouble-blindSupportive care

Summary

The main purpose of this study is to determine whether the opioid antagonist naltrexone is helpful in ameliorating the weight gain and other adverse metabolic side effects experienced by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa. Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa will normalize subjective pain ratings. Our tertiary objective is to examine the safety and tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.

Timeline

Start
2006-12
Primary completion
2010-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naltrexone Small molecule 50 mg

Indications