Status:
COMPLETED
Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
P2D, Inc.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
22-55 years
Phase:
PHASE1
Brief Summary
This study will determine whether the drug betahistine increases focus and causes side effects in people with attention deficit hyperactivity disorder.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is a disorder in which problems with paying attention and focusing disrupt people's lives. Betahistine is a drug that activates histamine, a compound fo...
Eligibility Criteria
Inclusion
- Diagnosis of attention deficit hyperactivity disorder (ADHD), combined subtype, using DSM-IV 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
- Known allergies to betahistine
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00829881
Start Date
January 1 2009
End Date
December 1 2009
Last Update
September 26 2013
Active Locations (1)
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1
University of Cincinnati; Department of Psychiatry
Cincinnati, Ohio, United States, 45219