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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Betahistine

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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:

The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
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.
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.

Sites / Locations

Nathan Kline Insitute for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Subjects assigned to this arm will receive Betahistine.

Subjects in this group will received placebo.

Outcomes

Primary Outcome Measures

Change in Weight

Least Squares estimated change in weight from end of study minus baseline

Secondary Outcome Measures

Change in Body Mass Index (BMI)

Least Squares estimated change in BMI from end of study minus baseline

Change in Waist Circumference

Least Squares estimated change in waist circumference from end of study minus baseline

Change in Hip Circumference

Least Squares estimated change in hip circumference from end of study minus baseline

Change in Glucose

Least Squares estimated change in glucose from end of study minus baseline

Change in Cholesterol

Least Squares estimated change in cholesterol from end of study minus baseline

Change in LDL

Least Squares estimated change in LDL from end of study minus baseline

Change in HDL

Least Squares estimated change in HDL from end of study minus baseline

Change in Triglycerides

Least Squares estimated change in triglycerides from end of study minus baseline

Change in Appetite Hunger

Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How Hungry do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.

Change in Appetite Fullness

Least Squares estimated change in appetite fullness from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How full do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"). indicate amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m.) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.

Full Information

NCT ID

NCT00709202

First Posted

July 1, 2008

Last Updated

January 20, 2019

Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

Stanley Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00709202

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Subjects assigned to this arm will receive Betahistine.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Subjects in this group will received placebo.

Intervention Type

Drug

Intervention Name(s)

Betahistine

Other Intervention Name(s)

Serc, Betaserc, Betaserk

Intervention Description

Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Primary Outcome Measure Information:

Title

Change in Weight

Description

Least Squares estimated change in weight from end of study minus baseline

Time Frame

Measured at each visit from baseline to end of study over a 12 week period

Secondary Outcome Measure Information:

Title

Change in Body Mass Index (BMI)

Description

Least Squares estimated change in BMI from end of study minus baseline

Time Frame