Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01012375

Enrollment

135

Registered

2009-11-13

Start date

2009-11-30

Completion date

2010-08-31

Last updated

2011-09-02

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

Conditions

Adult ADHD

Keywords

Adult ADHD

Brief 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.

Interventions

DRUGAZD1446

10 mg capsule, oral dose

DRUGPlacebo

Matching capsule, oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* A confirmed diagnosis of ADHD * Patient understands and is willing to comply with all study requirements * Adults between the ages of 18-65 inclusive

Exclusion criteria

* Current psychiatric disorder other than ADHD * Previous randomization into this study * Women with a positive pregnancy test

Design outcomes

Primary

Measure	Time frame
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)	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

Measure	Time frame
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	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.	From enrollment visit to follow up
To evaluate the pharmacokinetics (PK) of AZD1446.	Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected

Countries

United States

Outcome results

None listed

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