To Examine the Effect of Betahistine on Antipsychotic Induced Weight Gain in Adolescents - Full Text View

Sponsors and Collaborators:	Nathan Kline Institute for Psychiatric Research Stanley Medical Research Institute
Information provided by:	Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:	NCT00709202

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.

Our 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	Drug: Betahistine	Phase II

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Betahistine Betahistine dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents Using Betahistine: A Double-Blind, Placebo-Controlled Trial

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 ] [ 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 baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Placebo Comparator 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.

Detailed Description:

Subjects for this study will be children and adolescents from age 12 to age 18. 40 individuals ages 12-18 who have been psychiatrically stabilized on Clozapine, 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 18 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

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

Contacts

Contact: Melissa Benedict, M.A.	845-398-5525	Benedict@nki.rfmh.org
Contact: Alexis Moreno, B.A.	845-398-2184	AMoreno@nki.rfmh.org

Locations

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

Principal Investigator:

Lawrence A Maayan, M.D.

Nathan Kline Institute for Psychiatric Research

More Information

Responsible Party:	Nathan Kline Insitute for Psychiatric Research/ NYU Child Study Center ( Lawrence A. Maayan, M.D. )
Study ID Numbers:	07TGF-1112
Study First Received:	July 1, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00709202
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Body Weight
Signs and Symptoms
Mental Disorders
Body Weight Changes
Histamine phosphate

Betahistine
Psychotic Disorders
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Histamine

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Histamine Agonists

Therapeutic Uses
Physiological Effects of Drugs
Histamine Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009