Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adult ADHD

Intervention / Treatment
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* Drug: AZD1446
* Drug: AZD1446
* Drug: AZD1446
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1446 tid | Drug: AZD1446<br>* 10 mg capsule, oral dose<br>|
| Experimental: 2<br>AZD1446 tid | Drug: AZD1446<br>* 80 mg capsule, oral dose<br>|
| Experimental: 3<br>AZD1446 qd | Drug: AZD1446<br>* 80 mg capsule, oral dose<br>|
| Placebo Comparator: 4<br>Matching placebo capsule | Drug: Placebo<br>* Matching capsule, oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15 | 
| To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo. |  | From enrollment visit to follow up | 
| To evaluate the pharmacokinetics (PK) of AZD1446. |  | Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult ADHD