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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Nathan Kline Institute for Psychiatric Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00709202
First received: July 1, 2008
Last updated: June 7, 2011
Last verified: June 2011
  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 Young 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 2012
Estimated Primary Completion Date: April 2012 (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:   12 Years to 39 Years
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
  • Subjects must be on either Olanzapine, Seroquel, Clozapine or Risperdal for less than 6 weeks and have gained at least 2% of the body weight during that time.

Exclusion Criteria:

  • Subjects who have diabetes, hyper or hypothyroidism or other metabolic abnormalities.
  • Females who are pregnant or breast-feeding.
  • Diagnosis of asthma or peptic ulcer disease.
  • Antihypertensive agents, Metformin, lipid-lowering agents, thyroid r replacement therapy
  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: Lawrence Maayan, M.D. 845-398-6637 lmaayan@nki.rfmh.org
Contact: Allison Larr, B.A. 845-398-5486 Alarr@nki.rfmh.org

Locations
United States, New York
Nathan Kline Insitute for Psychiatric Research Recruiting
Orangeburg, New York, United States, 10962
Contact: Lawrence Maayan, M.D.    845-398-6637    lmaayan@nki.rfmh.org   
Contact: Allison Larr, B.A.    845-398-5486    Alarr@nki.rfmh.org   
Principal Investigator: Lawrence A Maayan, M.D.         
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Stanley Medical Research Institute
Investigators
Principal Investigator: Lawrence A Maayan, M.D. Nathan Kline Institute for Psychiatric Research
  More Information

No publications provided

Responsible Party: Lawrence A. Maayan, M.D., Nathan Kline Insitute for Psychiatric Research/ NYU Child Study Center
ClinicalTrials.gov Identifier: NCT00709202     History of Changes
Other Study ID Numbers: 07TGF-1112
Study First Received: July 1, 2008
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Schizophrenia and Disorders with Psychotic Features
Autistic Disorder
Schizophrenia
Weight Gain
Child Development Disorders, Pervasive
Body Weight Changes
Body Weight
Signs and Symptoms
Betahistine
Antipsychotic Agents
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 20, 2014