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

Phase 2

Completed

• Conditions: Adult ADHD
• Interventions: Drug: AZD1446; Drug: Placebo

• Registration Number: NCT01012375
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1446	AZD1446 tid
2	AZD1446	AZD1446 tid
3	AZD1446	AZD1446 qd
4	Placebo	Matching placebo capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States