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

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.

Study Overview

• Status: Completed
• Conditions: Adult ADHD
• Intervention / Treatment: Drug: AZD1446; Drug: AZD1446; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Alamitos, California, United States
      • Research Site
  • Florida
    • Ft Myers, Florida, United States
      • Research Site
  • New York
    • New York, New York, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
  • Vermont
    • Burlington, Vermont, United States
      • Research Site
  • Washington
    • Seattle, Washington, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; AZD1446 tid	Drug: AZD1446; 10 mg capsule, oral dose; Drug: AZD1446; 80 mg capsule, oral dose
EXPERIMENTAL: 2; AZD1446 tid	Drug: AZD1446; 10 mg capsule, oral dose; Drug: AZD1446; 80 mg capsule, oral dose
EXPERIMENTAL: 3; AZD1446 qd	Drug: AZD1446; 10 mg capsule, oral dose; Drug: AZD1446; 80 mg capsule, oral dose
PLACEBO_COMPARATOR: 4; Matching placebo capsule	Drug: Placebo; Matching capsule, oral dose

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Paul A Newhouse, MD, Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401; Study Director: Bjorn Paulsson, MD, AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: November 11, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (ESTIMATE): November 13, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 2, 2011
• Last Update Submitted That Met QC Criteria: August 31, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Adult ADHD
• Other Study ID Numbers: D1950C00007