Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder
NCT ID: NCT00829881
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2009-01-31
2009-12-31
Brief Summary
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Detailed Description
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Participation in this study will last approximately 4 weeks. Participants will first attend a screening visit that will include a review of their medical and psychiatric history, a physical examination, vital signs measurements, an electrocardiogram (EKG) test, blood and urine sample collection, an eating questionnaire, and a clinical interview to confirm an ADHD diagnosis. Eligible participants will then be randomly assigned to receive either betahistine or placebo on subsequent study visits.
Participants will then attend three weekly study visits, starting 1 week after completing screening. At each visit, participants will receive a dose of either betahistine or placebo. The dose of betahistine will increase at each visit, starting at 50 mg, then increasing to 100 mg, and then to 200 mg. Participants will be asked to refrain from eating and to drink only water in the 12 hours prior to study visits. Also at each visit, participants will have their vital signs measured, complete questionnaires concerning appetite and mood, perform attention and memory tests, provide several blood samples, undergo an EKG test, and perform a breathing test. Some of these tests will be repeated several times over the course of each study visit. Additionally, at the last study visit, participants will undergo a physical examination and provide urine samples.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants will receive a placebo capsule, administered orally, once per study visit.
Placebo Capsule
A single placebo capsule
2
Participants will receive a betahistine capsule, administered orally, once per study visit.
Betahistine Hydrochloride
A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks
Interventions
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Betahistine Hydrochloride
A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks
Placebo Capsule
A single placebo capsule
Eligibility Criteria
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Inclusion Criteria
* Otherwise healthy, as determined by medical history, physical examination, and clinical laboratory tests
* Symptomatic impairment with ADHD, as evidenced by a symptom severity score of 20 or greater on the 18-item ADHD total symptom score of the Conners Adult ADHD Rating Scales (CAARS)
* Body mass index (BMI) less than or equal to 32.4 kg/m2, with a waist circumference less than or equal to 40 inches for males
Exclusion Criteria
* Participation in a study involving administration of an investigational compound within the past month
* Pregnant
* Positive for HIV, hepatitis B antigen, or hepatitis C antibody
* Use of illicit drugs (excluding psychostimulants for ADHD) or alcohol
* History of drug addiction or alcohol abuse requiring treatment within the past 12 months
* History of asthma, peptic ulcer disease, or pheochromocytoma
* History of any other illness or condition that, in the opinion of the principal investigator, might interfere with study participation, confound the results of the study, or pose additional risk to the subject
22 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
P2D, Inc.
INDUSTRY
Responsible Party
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P2D, Inc.
Principal Investigators
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Charles H. Pierce, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
P2D, Inc.
Locations
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University of Cincinnati; Department of Psychiatry
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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