Attention Deficit Disorder With HyperactivityPhase 1NCT00829881
Effects of Using Betahistine to Treat Adults With Attention Deficit Hyperactivity Disorder
A Phase 1 study testing Betahistine Hydrochloride in people with Attention Deficit Disorder With Hyperactivity, run by P2D, Inc. at 1 site in United States.
Trial summary
This study will determine whether the drug betahistine increases focus and causes side effects in people with attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Betahistine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati; Department of Psychiatry
Cincinnati, Ohio, 45219
About this study
Official title: 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.
Read the 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.
- Being tested
- Betahistine Hydrochloride, Placebo Capsule
- Keywords
- Attention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betahistine HydrochlorideDrug
A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks
Placebo CapsuleDrug
A single placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Participants will receive a placebo capsule, administered orally, once per study visit. Receives: Drug: Placebo Capsule |
| 2 | Experimental | Participants will receive a betahistine capsule, administered orally, once per study visit. Receives: Drug: Betahistine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention, measured on the Continuous Performance Test through the signal detection parameter or stimulus detectability
Measured: Measured 2 and 4 hours after dosing at each of three study visits
Secondary outcomes (1)
Adverse events
Measured: Measured throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- P2D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Charles H. Pierce, MD, PhD, Principal investigator, P2D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829881
- Sponsor's protocol ID
- R43MH082461
- Other IDs
- R43MH082461, MH082461, DNBBS BT-BU
- Status last verified
- Sep 2013
- First submitted
- 26 Jan 2009
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betahistine: Novel Therapeutic in Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00829881
- Acronym / sponsor ID
- R43MH082461
- Keywords
- Attention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- P2D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo CapsuleParticipants will receive a placebo capsule, administered orally, once per study visit. |
| 2 | Experimental | Drug: Betahistine HydrochlorideParticipants will receive a betahistine capsule, administered orally, once per study visit. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betahistine HydrochlorideA single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks | Drug | 2 |
| Placebo CapsuleA single placebo capsule | Drug | 1 |
Primary outcome
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
1 secondary outcome
Adverse events
Time frame: Measured throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles H. Pierce, MD, PhD principal investigator
P2D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betahistine Hydrochloride in people with Attention Deficit Disorder With Hyperactivity, run by P2D, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.