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

NCT00829881 | Completed Phase 1

• 3 other identifiers: R43MH082461MH082461DNBBS BT-BU
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  Measured throughout the study

Study Arms (2)

1

PLACEBO COMPARATOR

Participants will receive a placebo capsule, administered orally, once per study visit.

Drug: Placebo Capsule

2

EXPERIMENTAL

Participants will receive a betahistine capsule, administered orally, once per study visit.

Drug: Betahistine Hydrochloride

Interventions

Betahistine Hydrochloride DRUG

A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks

2

Placebo Capsule DRUG

A single placebo capsule

1

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• P2D, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Cincinnati; Department of Psychiatry

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Charles H. Pierce, MD, PhD

  P2D, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

US (1)