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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
P2D, Inc.
ClinicalTrials.gov Identifier:
NCT00829881
First received: January 26, 2009
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Betahistine Hydrochloride
Drug: Placebo Capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Betahistine: Novel Therapeutic in Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by P2D, Inc.:

Primary Outcome Measures:
  • Attention, measured on the Continuous Performance Test through the signal detection parameter or stimulus detectability [ Time Frame: Measured 2 and 4 hours after dosing at each of three study visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   22 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829881

Locations
United States, Ohio
University of Cincinnati; Department of Psychiatry
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
P2D, Inc.
Investigators
Principal Investigator: Charles H. Pierce, MD, PhD P2D, Inc.
  More Information

No publications provided

Responsible Party: Charles H. Pierce, MD, PhD, CPI, P2D, Inc.
ClinicalTrials.gov Identifier: NCT00829881     History of Changes
Other Study ID Numbers: R43 MH082461, R43MH082461, MH082461, DNBBS BT-BU
Study First Received: January 26, 2009
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by P2D, Inc.:
Attention

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Betahistine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014