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

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ClinicalTrials.gov Identifier: NCT00683462
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : October 30, 2009
Sponsor:
Collaborator:
Targacept Inc.
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ADHD Drug: Placebo Drug: AZD3480 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : May 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Experimental: 2 Drug: AZD3480
Capsules 5 mg/day (once a day) for 2 weeks

Experimental: 3 Drug: AZD3480
Capsules 50 mg/day (once a day) for 2 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683462


Locations
United States, Vermont
Research Site
Burlington, Vermont, United States
Sponsors and Collaborators
AstraZeneca
Targacept Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director AZD3480, AstraZeneca R&D, Södertälje
ClinicalTrials.gov Identifier: NCT00683462     History of Changes
Obsolete Identifiers: NCT00683215
Other Study ID Numbers: TC-1734-226-CRD-005
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders