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

NCT ID: NCT00683462

Last Updated: 2009-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

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

3

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

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

Interventions

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Placebo

Intervention Type DRUG

AZD3480

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

Intervention Type DRUG

AZD3480

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Targacept Inc.

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D, Södertälje

Locations

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Research Site

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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Potter AS, Dunbar G, Mazzulla E, Hosford D, Newhouse PA. AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults. Biol Psychiatry. 2014 Feb 1;75(3):207-14. doi: 10.1016/j.biopsych.2013.06.002. Epub 2013 Jul 12.

Reference Type DERIVED
PMID: 23856296 (View on PubMed)

Other Identifiers

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TC-1734-226-CRD-005

Identifier Type: -

Identifier Source: org_study_id

NCT00683215

Identifier Type: -

Identifier Source: nct_alias