drugset / Trial / NCT00636896
Effects of Modafinil on Olanzapine Weight Gain
Completed
50 enrolled
Neuropsychiatric Research Institute, Fargo, North Dakota
Eli Lilly and Company · collabUniversity of North Dakota · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This study is designed as a 3 week, randomized, double blind, placebo controlled, trial. Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety, kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be drawn at baseline and endpoint prior to breakfast and two hours post. Study hypothesis: The modafinil/olanzapine group will gain less weight than the olanzapine/placebo group over three weeks of drug intake.
Timeline
- Start
- 2006-07
- Primary completion
- 2007-08
- Completion
- 2007-08
Publications
- Background Roerig JL, Steffen KJ, Mitchell JE, Crosby RD, Gosnell BA. A comparison of the effects of olanzapine and risperidone versus placebo on ghrelin plasma levels. J Clin Psychopharmacol. 2008 Feb;28(1):21-6. doi: 10.1097/jcp.0b013e3181613325.
- Background Roerig JL, Mitchell JE, de Zwaan M, Crosby RD, Gosnell BA, Steffen KJ, Wonderlich SA. A comparison of the effects of olanzapine and risperidone versus placebo on eating behaviors. J Clin Psychopharmacol. 2005 Oct;25(5):413-8. doi: 10.1097/01.jcp.0000177549.36585.29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Modafinil | Small molecule | 200 mg | — |
| Background | Olanzapine | Small molecule | 10 mg | — |
Indications
No indication recorded.