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

NCT00709202 | Completed Phase 2 Results

• 1 other identifier: 07TGF-1112
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Weight

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

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

Secondary Outcomes (10)

• Change in Body Mass Index (BMI)

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

• Change in Waist Circumference

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

• Change in Hip Circumference

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

• Change in Glucose

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

• Change in Cholesterol

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

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects assigned to this arm will receive Betahistine.

Drug: Betahistine

2

PLACEBO COMPARATOR

Subjects in this group will received placebo.

Drug: Placebo Oral Tablet

Interventions

Betahistine DRUG

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

Also known as: Serc, Betaserc, Betaserk

1

Placebo Oral Tablet DRUG

2

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Nathan Kline Insitute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

• Kang D, Jing Z, Li R, Hei G, Shao T, Li L, Sun M, Yang Y, Wang Y, Wang X, Long Y, Huang X, Wu R. Effect of Betahistine and Metformin on Antipsychotic-Induced Weight Gain: An Analysis of Two Clinical Trials. Front Psychiatry. 2018 Nov 27;9:620. doi: 10.3389/fpsyt.2018.00620. eCollection 2018.

  PMID: 30542300 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Autism Spectrum Disorder

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Robert C Principal Investigator. Smith,
• Organization: Nathan Kline Institute for Psychiatric Research

robert.smith@nki.rfmh.org

845-398-6531

Study Officials

• Robert C Smith, M.D.

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist, Research Professor of Psychiatry

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)