ADHDPhase 2NCT00683462
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing AZD3480 in people with ADHD, run by AstraZeneca at 1 site in United States.
Trial summary
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- AZD3480
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2009
- 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
- Confirmed diagnosis of DSM-IV ADHD
- Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
- Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test
Who cannot join
- Current DSM-IV Axis I psychiatric disorder (other than ADHD)
- Current user of cigarettes or other nicotine-containing product.
- Slow metabolizers as indicated by CYP2D6 genotyping.
- Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.
Trial locations and contacts
1 site in 1 country.
About this study
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.
- Conditions
- ADHD
- Being tested
- Placebo, AZD3480
- 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.
PlaceboDrug
AZD3480Drug
Capsules 5 mg/day (once a day) for 2 weeks
AZD3480Drug
Capsules 50 mg/day (once a day) for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: AZD3480 |
| 3 | Experimental | Not described Receives: Drug: AZD3480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
Measured: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Secondary outcomes (3)
Clinical Global Impressions Scales (NIMH 1985)
Measured: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery
Measured: 2, 3, 5, 8, 10, 13, 15
CNRU computerized cognitive battery
Measured: 2, 3, 5, 8, 10, 13, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Targacept Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683462
- Sponsor's protocol ID
- TC-1734-226-CRD-005
- Status last verified
- Oct 2009
- First submitted
- 21 May 2008
- Last updated
- 30 Oct 2009
- Results posted
- No
Publications
Potter AS, Dunbar G, Mazzulla E, Hosford D, Newhouse PA. AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults. Biol Psychiatry. 2014 Feb 1;75(3):207-14. doi: 10.1016/j.biopsych.2013.06.002. Epub 2013 Jul 12.
PubMed 23856296
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00683462
- Acronym / sponsor ID
- TC-1734-226-CRD-005
- Conditions
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Targacept Inc.
- Study start
- May 2008
- Study completion
- Jul 2009 (actual)
- First posted
- 23 May 2008 (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.
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: AZD3480 |
| 3 | Experimental | Drug: AZD3480 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of DSM-IV ADHD
- Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
- Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test
Key exclusion criteria (4 listed)
- Current DSM-IV Axis I psychiatric disorder (other than ADHD)
- Current user of cigarettes or other nicotine-containing product.
- Slow metabolizers as indicated by CYP2D6 genotyping.
- Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.
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 |
|---|---|---|
| Placebo | Drug | 1 |
| AZD3480Capsules 5 mg/day (once a day) for 2 weeks | Drug | 2 |
| AZD3480Capsules 50 mg/day (once a day) for 2 weeks | Drug | 3 |
Primary outcome
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
Time frame: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
3 secondary outcomes
Clinical Global Impressions Scales (NIMH 1985)
Time frame: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery
Time frame: 2, 3, 5, 8, 10, 13, 15
CNRU computerized cognitive battery
Time frame: 2, 3, 5, 8, 10, 13, 15
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 30 Oct 2009.
- Derived from this study: PubMed 23856296Potter AS, Dunbar G, Mazzulla E, Hosford D, Newhouse PA. AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults. Biol Psychiatry. 2014 Feb 1;75(3):207-14. doi: 10.1016/j.biopsych.2013.06.002. Epub 2013 Jul 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD3480 in people with ADHD, run by AstraZeneca 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 3 inclusion and 4 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 30 Oct 2009. 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 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?
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV). (time frame: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683462, which also lists 1 linked publication.
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 30 Oct 2009.