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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: P2D, Inc.
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Betahistine

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