drugset / Trial / NCT00567034
Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naltrexone | Small molecule | 50 mg | — |