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

Primary Purpose

ADHD

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

AZD3480

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Global Impressions Scales (NIMH 1985)

CDR computerized cognitive battery

CNRU computerized cognitive battery

Full Information

NCT ID

NCT00683462

First Posted

May 21, 2008

Last Updated

October 29, 2009

Sponsor

AstraZeneca

Collaborators

Targacept Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00683462

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

Collaborators

Targacept Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

AZD3480

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AZD3480

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Clinical Global Impressions Scales (NIMH 1985)

Time Frame

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

Title

CDR computerized cognitive battery

Time Frame

2, 3, 5, 8, 10, 13, 15

Title

CNRU computerized cognitive battery

Time Frame

2, 3, 5, 8, 10, 13, 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Research Site

City

Burlington

State/Province

Vermont

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23856296

Citation

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.

Results Reference

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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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