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Completed

NCT Number: NCT00683462

An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.

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Key information

Conditions

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

Burlington, Vermont, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of DSM-IV ADHD
  • Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
  • Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test

Exclusion criteria

  • Current DSM-IV Axis I psychiatric disorder (other than ADHD)
  • Current user of cigarettes or other nicotine-containing product.
  • Slow metabolizers as indicated by CYP2D6 genotyping.
  • Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.

Treatment and study plan

Placebo

Drug

AZD3480

Drug

Capsules 5 mg/day (once a day) for 2 weeks

Primary outcomes

  1. The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).

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

Secondary outcomes

  1. Clinical Global Impressions Scales (NIMH 1985)

    Time frame: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15

  2. CDR computerized cognitive battery

    Time frame: 2, 3, 5, 8, 10, 13, 15

  3. CNRU computerized cognitive battery

    Time frame: 2, 3, 5, 8, 10, 13, 15

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Targacept Inc.

Registry information

Important dates

Study start
2008
Study completion
2009
First posted
May 23, 2008
Registry last updated
Oct 30, 2009

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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