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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1446 tid |
|
| 2 | Experimental | AZD1446 tid |
|
| 3 | Experimental | AZD1446 qd |
|
| 4 | Placebo Comparator | Matching placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | 10 mg capsule, oral dose |
| |
| AZD1446 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Newhouse, MD | Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401 | Principal Investigator |
| Bjorn Paulsson, MD | AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Alamitos | California | United States | |||
| Research Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2014 | |
| Reset | Aug 13, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2014 | Aug 13, 2014 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
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| Drug |
80 mg capsule, oral dose |
|
| AZD1446 | Drug | 80 mg capsule, oral dose |
|
| Placebo | Drug | Matching capsule, oral dose |
|
| 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 |
| Fort Myers |
| Florida |
| United States |
| Research Site | New York | New York | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Burlington | Vermont | United States |
| Research Site | Seattle | Washington | United States |