Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain in Adolescents and Young Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Nathan Kline Institute for Psychiatric Research
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00709202
First received: July 1, 2008
Last updated: May 4, 2016
Last verified: May 2016
  Purpose

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.

The investigators hypotheses therefore are as follows:

  • Youth who have gained a developmentally inappropriate amount of weight on SGAs will see their weight stabilize or even decrease with betahistine augmentation as compared to placebo augmentation.
  • Betahistine augmentation in SGA treated youth will increase levels of satiety in a standardized meal situation and decrease caloric intake.as compared to placebo augmentation.
  • Metabolic effects of betahistine augmentation in SGA treated youth will be reflected in a normalization of adipose distribution when compared to placebo augmentation, in particular with regards to the ratio of visceral to peripheral adipose tissue.
  • Betahistine augmentation in this population will lead to a normalization in physiologic and lab values related to the development of metabolic syndrome as compared to placebo augmentation.

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform;
Bipolar I Disorder
Bipolar II
Bipolar NOS
Psychotic Disorder Not Otherwise Specified
Autism
Drug: Betahistine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Changes in weight and BMI [ Time Frame: Measured at each visit over a 12 week period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in satiety after a standardized meal, cholesterol, insulin, glucose and leptin levels as well as waist and hip measurements [ Time Frame: Measured at week 0 and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Serc, Betaserc, Betaserk
Placebo Comparator: 2
Subjects in this group will received placebo.
Drug: Betahistine
Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.
Other Name: Serc, Betaserc, Betaserk

Detailed Description:
Subjects for this study will be adolescents and young adults from age 12 to age 18. 40 individuals ages 12-39 who have been psychiatrically stabilized on Cloz39ine, Olanzapine, Risperdal, or Seroquel, and have gained more than 2% of their weight in their first 6 weeks on these medications will be recruited to participate. Subjects will be 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 will be randomized to receive either betahistine or placebo at a 1:1 ratio.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents ages 12-18 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS
  • Patients will be currently treated with antipsychotics and will have a have a diagnosis of schizophrenia spectrum disorders (including schizoaffective disorder), bipolar disorder, or autism spectrum disorder.

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 a year 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709202

Contacts
Contact: Robert C Smith, M.D. 845-398-6531 lmaayan@nki.rfmh.org
Contact: Muhammed Sharifi, MD 845-398-2890 Alarr@nki.rfmh.org

Locations
United States, New York
Nathan Kline Insitute for Psychiatric Research Recruiting
Orangeburg, New York, United States, 10962
Contact: Robert C Smith, M.D.    845-398-6531    rsmith@nki.rfmh.org   
Contact: Muhammed Sharifi, M.D.    845-398-6280    Muhammed.Sharifi@nki.rfmh.org   
Principal Investigator: Robert C Smith, M.D.         
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Stanley Medical Research Institute
Investigators
Principal Investigator: Robert C Smith, M.D. Nathan Kline Institute for Psychiatric Research
  More Information

Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, ResearcghProfessor of Psychiatry, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00709202     History of Changes
Other Study ID Numbers: 07TGF-1112 
Study First Received: July 1, 2008
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Body Weight Changes
Disease
Schizophrenia
Psychotic Disorders
Weight Gain
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Body Weight
Signs and Symptoms
Antipsychotic Agents
Betahistine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Vasodilator Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016