Clinical trial NCT01012375: Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
Official title: A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety ,Tolerability and Pharmacokinetics of Three Oral AZD1446 Dose Regimens and Placebo During 2 Weeks of Treatment in Adult Non-Users and Users of Nicotine Containing Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult ADHD
Keywords: Adult ADHD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.


Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of ADHD
* Patient understands and is willing to comply with all study requirements
* Adults between the ages of 18-65 inclusive

Exclusion Criteria:

* Current psychiatric disorder other than ADHD
* Previous randomization into this study
* Women with a positive pregnancy test

Primary outcomes:
measure: AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
timeFrame: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
Secondary outcomes:
measure: To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring
timeFrame: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
measure: To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.
timeFrame: From enrollment visit to follow up
measure: To evaluate the pharmacokinetics (PK) of AZD1446.
timeFrame: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Research Site
state: California
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: New York
country: United States
facility: Research Site
state: New York
city: Austin
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401
name: Paul A Newhouse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden
name: Bjorn Paulsson, MD
role: STUDY_DIRECTOR
References: