drugset / Trial / NCT00709202

Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain

NCT00709202

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation. B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation. C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation

Timeline

Start
2008-07
Primary completion
2016-05
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Betahistine Small molecule 24 mg