Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Schizophrenia, Neurology, Psychiatric, Bipolar Disorder, Autism |
| Therapuetic Areas: | Endocrinology, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 1/27/2019 |
| Start Date: | July 2008 |
| End Date: | December 2016 |
The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial
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
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
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.
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.
Inclusion Criteria:
- Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective
Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder
NOS, Autism Spectrum Disorder
- Patients will be currently treated with antipsychotics
Patients will qualify for entry if they meet the following weight criteria:
1. The patient has gained 7% of their weight since beginning of treatment with one or
more of the current antipsychotics.
2. The patient has had an increase of 7% of their weight during the last year while being
treated with antipsychotics.
3. The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months
while being treated with antipsychotic medications.
4. The patient has a BMI of 35 or greater at the current time, and his chart shows a
history of consistent weight gain over the past 1 to 3 years during treatment with
antipsychotics.
Exclusion Criteria:
- Subjects will be excluded if they have asthma, peptic ulcer disease (diseases
which may be exacerbated by a histamine analog), or history of pheochromocytoma
or peptic ulcer disease. Patients will be excluded if they are prescribed
medications known to affect body weight or glucose-lipid metabolism, such as
prescription or over the counter medications taken for the purpose of weight
reduction. Subjects who are currently treated with metformin, for less than 6
months and have shown recent weight change on metformin. Patients on thyroid
replacement therapy or lipid-lowering agents whose dosage has changed by more
than 50 % in the past month will be excluded. If they are relatively stable doses
of these medications they will not be excluded. Patients who are on lipid
lowering medication, thyroid replacement medication, or diabetes medication,
(excluding metformin), must remain on these medications throughout the period of
the study. Females who are pregnant or breast feeding will be excluded.
We found this trial at
1
site
Orangeburg, New York 10962
Principal Investigator: Robert C Smith, M.D.
Phone: 845-398-6531
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