NCT00709202

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

The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nathan Kline Institute for Psychiatric Research · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were individuals who have been psychiatrically stabilized on first or second generation antipsychotic medication, and have gained substantial weight during their treatment. Subjects were excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog) or are prescribed medications known to affect body composition or metabolism other than those currently being studied. Subjects were randomized to receive either betahistine or placebo at a 1:1 ratio.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder
• Bipolar I Disorder
• Bipolar II
• Bipolar NOS(Not Otherwise Specified)
• Psychotic Disorder Not Otherwise Specified
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Betahistine	Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..
DRUG	Placebo Oral Tablet

Timeline

• Start date: 2008-07-01
• Primary completion: 2016-05-01
• Completion: 2016-12-01
• First posted: 2008-07-03
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

1 site across 1 country: United States