Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain in Adolescents and Young Adults
This study is currently recruiting participants.
Verified June 2011 by Nathan Kline Institute for Psychiatric Research
Sponsor:
Nathan Kline Institute for Psychiatric Research
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
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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:
MedlinePlus related topics:
Autism
Child Mental Health
Mental Disorders
Psychotic Disorders
Schizophrenia
U.S. FDA Resources
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
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 |
Histamine Agonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Therapeutic Uses Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013