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Completed

NCT Number: NCT01012375

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

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.

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Key information

Conditions

Adult ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Los Alamitos, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1446

Drug

10 mg capsule, oral dose

Placebo

Drug

Matching capsule, oral dose

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. 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

    Time frame: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15

  2. To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.

    Time frame: From enrollment visit to follow up

  3. To evaluate the pharmacokinetics (PK) of AZD1446.

    Time frame: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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