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

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ClinicalTrials.gov Identifier: NCT00709202
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research

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


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Bipolar I Disorder Bipolar II Bipolar NOS(Not Otherwise Specified) Psychotic Disorder Not Otherwise Specified Autism Spectrum Disorder Drug: Betahistine Drug: Placebo Oral Tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial
Study Start Date : July 2008
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: 1
Subjects assigned to this arm will receive Betahistine.
Drug: Betahistine
Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..
Other Name: Serc, Betaserc, Betaserk

Placebo Comparator: 2
Subjects in this group will received placebo.
Drug: Placebo Oral Tablet



Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period ]
    Least Squares estimated change in weight from end of study minus baseline


Secondary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in BMI from end of study minus baseline

  2. Change in Waist Circumference [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in waist circumference from end of study minus baseline

  3. Change in Hip Circumference [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in hip circumference from end of study minus baseline

  4. Change in Glucose [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in glucose from end of study minus baseline

  5. Change in Cholesterol [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in cholesterol from end of study minus baseline

  6. Change in LDL [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in LDL from end of study minus baseline

  7. Change in HDL [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in HDL from end of study minus baseline

  8. Change in Triglycerides [ Time Frame: Measured at each visit from baseline to end of study over a 12 week period. ]
    Least Squares estimated change in triglycerides from end of study minus baseline

  9. Change in Appetite Hunger [ Time Frame: Measured at baseline and 12 weeks ]
    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.

  10. Change in Appetite Fullness [ Time Frame: .Measured at baseline and 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709202


Locations
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United States, New York
Nathan Kline Insitute for Psychiatric Research
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Stanley Medical Research Institute
Investigators
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Principal Investigator: Robert C Smith, M.D. Nathan Kline Institute for Psychiatric Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, Research Professor of Psychiatry, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00709202    
Other Study ID Numbers: 07TGF-1112
First Posted: July 3, 2008    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Disease
Weight Gain
Schizophrenia
Autism Spectrum Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Body Weight Changes
Body Weight
Betahistine
Vasodilator Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs