Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Summary
The goal of this study is to answer the following questions: * Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine * Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain * How weight gain associated with olanzapine can affect people * Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases
Timeline
- Start
- 2006-11
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Missed primary endpoint
paper Mean weight gain during olanzapine treatment did not differ significantly from pooled results for olanzapine + A and olanzapine + B (P = .065). PMID 21672497 ↗
Publications
- Hoffmann VP, Case M, Jacobson JG. Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. J Clin Psychiatry. 2012 Feb;73(2):216-23. doi: 10.4088/JCP.09m05580. Epub 2011 May 17.
- Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | 100 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
| Subject | Olanzapine | Small molecule | 20 mg | Oral |
| Subject | Zonisamide | Other / unclassified | 100 mg | Oral |
| Subject | Zonisamide | Other / unclassified | 400 mg | Oral |