Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder

Betahistine: Novel Therapeutic in Attention Deficit Hyperactivity Disorder

This study will determine whether the drug betahistine increases focus and causes side effects in people with attention deficit hyperactivity disorder.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: Placebo Capsule; Drug: Betahistine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati; Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Participants will receive a placebo capsule, administered orally, once per study visit.	Drug: Placebo Capsule; A single placebo capsule
Experimental: 2; Participants will receive a betahistine capsule, administered orally, once per study visit.	Drug: Betahistine Hydrochloride; A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attention, measured on the Continuous Performance Test through the signal detection parameter or stimulus detectability	Measured 2 and 4 hours after dosing at each of three study visits

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Measured throughout the study

Collaborators and Investigators

• Sponsor: P2D, Inc.
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Charles H. Pierce, MD, PhD, P2D, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: September 25, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Attention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Histamine Agents; Histamine Agonists; Betahistine
• Other Study ID Numbers: R43MH082461 (U.S. NIH Grant/Contract); MH082461; DNBBS BT-BU