An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683462

Enrollment

Registered

2008-05-23

Start date

2008-05-31

Completion date

2009-07-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Brief 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. 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.

Interventions

DRUGPlacebo

DRUGAZD3480

Capsules 5 mg/day (once a day) for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).	Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15

Secondary

Measure	Time frame
CNRU computerized cognitive battery	2, 3, 5, 8, 10, 13, 15
Clinical Global Impressions Scales (NIMH 1985)	Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery	2, 3, 5, 8, 10, 13, 15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026