Adult ADHDPhase 2NCT01012375
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
A Phase 2 study testing AZD1446 in people with Adult ADHD, run by AstraZeneca at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult ADHD
- What is being tested?
- AZD1446
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of ADHD
- Patient understands and is willing to comply with all study requirements
- Adults between the ages of 18-65 inclusive
Who cannot join
- Current psychiatric disorder other than ADHD
- Previous randomization into this study
- Women with a positive pregnancy test
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Austin, Texas
Research Site
Burlington, Vermont
Research Site
Fort Myers, Florida
Research Site
Los Alamitos, California
Research Site
New York, New York
Research Site
Seattle, Washington
About this study
Official title: A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety ,Tolerability and Pharmacokinetics of Three Oral AZD1446 Dose Regimens and Placebo During 2 Weeks of Treatment in Adult Non-Users and Users of Nicotine Containing Products
The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.
- Conditions
- Adult ADHD
- Being tested
- AZD1446, Placebo
- Keywords
- Adult ADHD
- 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.
AZD1446Drug
10 mg capsule, oral dose
AZD1446Drug
80 mg capsule, oral dose
AZD1446Drug
80 mg capsule, oral dose
PlaceboDrug
Matching capsule, oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1446 tid Receives: Drug: AZD1446 |
| 2 | Experimental | AZD1446 tid Receives: Drug: AZD1446 |
| 3 | Experimental | AZD1446 qd Receives: Drug: AZD1446 |
| 4 | Placebo comparator | Matching placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
Measured: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
Secondary outcomes (3)
To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring
Measured: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.
Measured: From enrollment visit to follow up
To evaluate the pharmacokinetics (PK) of AZD1446.
Measured: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ADHDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul A Newhouse, MD, Principal investigator, Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401Bjorn Paulsson, MD, Study director, AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012375
- Sponsor's protocol ID
- D1950C00007
- Status last verified
- Sep 2010
- First submitted
- 11 Nov 2009
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety ,Tolerability and Pharmacokinetics of Three Oral AZD1446 Dose Regimens and Placebo During 2 Weeks of Treatment in Adult Non-Users and Users of Nicotine Containing Products
- ClinicalTrials.gov ID
- NCT01012375
- Acronym / sponsor ID
- D1950C00007
- Conditions
- Adult ADHD
- Keywords
- Adult ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Nov 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.
The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1446AZD1446 tid |
| 2 | Experimental | Drug: AZD1446AZD1446 tid |
| 3 | Experimental | Drug: AZD1446AZD1446 qd |
| 4 | Placebo comparator | Drug: PlaceboMatching placebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A confirmed diagnosis of ADHD
- Patient understands and is willing to comply with all study requirements
- Adults between the ages of 18-65 inclusive
Key exclusion criteria (3 listed)
- Current psychiatric disorder other than ADHD
- Previous randomization into this study
- Women with a positive pregnancy test
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 |
|---|---|---|
| AZD144610 mg capsule, oral dose | Drug | 1 |
| AZD144680 mg capsule, oral dose | Drug | 2 |
| AZD144680 mg capsule, oral dose | Drug | 3 |
| PlaceboMatching capsule, oral dose | Drug | 4 |
Primary outcome
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
Time frame: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
3 secondary outcomes
To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring
Time frame: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.
Time frame: From enrollment visit to follow up
To evaluate the pharmacokinetics (PK) of AZD1446.
Time frame: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected
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 2 Sep 2011.
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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.
Paul A Newhouse, MD principal investigator
Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401
Bjorn Paulsson, MD study director
AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1446 in people with Adult ADHD, run by AstraZeneca at 6 sites 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 3 inclusion and 3 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 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item) (time frame: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15). 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 2 Sep 2011.