Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

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 found in the human body that regulates immune response and acts as a
      neurotransmitter. Increased availability of histamine in the brain is known to enhance
      attention and cognition. In previous studies, betahistine increased vigilance in healthy
      participants. Presently, betahistine is used outside the United States to treat vertigo, but
      at doses that are too low to have an effect on attention and cognition. Based on data
      regarding the use of betahistine outside the United States and on data from other studies
      using betahistine, there do not appear to be any significant side effects from its use at low
      doses. This study will determine both whether betahistine is effective in increasing
      vigilance in people with ADHD and whether it has any side effects at higher doses.

      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.
    

Intervention name(s): Betahistine Hydrochloride; Placebo Capsule
Intervention type(s): Drug; Drug
Intervention description(s): A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks; A single placebo capsule
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention