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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00709202 |
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Date of registration:
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01/07/2008 |
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Primary sponsor: |
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Public title:
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Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain in Adolescents and Young Adults
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Scientific title:
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The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Young Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00709202 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lawrence Maayan, M.D. |
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Address:
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Telephone:
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845-398-6637 |
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Email:
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lmaayan@nki.rfmh.org |
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Affiliation:
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Name:
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Lawrence Maayan, M.D. |
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Address:
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Telephone:
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845-398-6637 |
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Email:
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lmaayan@nki.rfmh.org |
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Affiliation:
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Name:
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Lawrence A Maayan, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nathan Kline Institute for Psychiatric Research |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
39 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autism
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Bipolar I Disorder
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Bipolar II
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Bipolar NOS
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Psychotic Disorder Not Otherwise Specified
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Schizoaffective Disorder
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Schizophrenia
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Schizophreniform;
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Intervention(s)
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Drug: Betahistine
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Primary Outcome(s)
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Changes in weight and BMI
[Time Frame: Measured at each visit over a 12 week period]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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07TGF-1112
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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