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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Adult ADHD

Treatments: Drug: Placebo; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012375

D1950C00007

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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135 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

AZD1446 tid

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

2

Experimental group

Description:

AZD1446 tid

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

3

Experimental group

Description:

AZD1446 qd

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

4

Placebo Comparator group

Description:

Matching placebo capsule

Treatment:

Drug: Placebo