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

AstraZeneca24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

ADHD

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Clinical Global Impressions Scales (NIMH 1985)

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

CDR computerized cognitive battery

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

CNRU computerized cognitive battery