Status:
COMPLETED
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were individuals who have been psychiatrically stabilized on first or second generation antipsychotic medication, an...
Eligibility Criteria
Inclusion
- Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder
- Patients will be currently treated with antipsychotics
- Patients will qualify for entry if they meet the following weight criteria:
- The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
- The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
- 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.
- 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
- 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 6 months 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00709202
Start Date
July 1 2008
End Date
December 1 2016
Last Update
January 25 2019
Active Locations (1)
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1
Nathan Kline Insitute for Psychiatric Research
Orangeburg, New York, United States, 10962