Clinical trial NCT00829881: Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder
Official title: Betahistine: Novel Therapeutic in Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention
Lead sponsor: P2D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Attention, measured on the Continuous Performance Test through the signal detection parameter or stimulus detectability
timeFrame: Measured 2 and 4 hours after dosing at each of three study visits
Secondary outcomes:
measure: Adverse events
timeFrame: Measured throughout the study
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati; Department of Psychiatry
state: Ohio
Study officials:
affiliation: P2D, Inc.
name: Charles H. Pierce, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: