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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683462
• Other study ID #: TC-1734-226-CRD-005
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2008
• Last updated: October 29, 2009
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00683215

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Placebo

• AZD3480
Capsules 5 mg/day (once a day) for 2 weeks
• AZD3480
Capsules 50 mg/day (once a day) for 2 weeks

Locations

Country	Name	City	State
United States	Research Site	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).		Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Secondary	Clinical Global Impressions Scales (NIMH 1985)		Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
Secondary	CDR computerized cognitive battery		2, 3, 5, 8, 10, 13, 15
Secondary	CNRU computerized cognitive battery		2, 3, 5, 8, 10, 13, 15