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This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-288 Dose 1 | Experimental | low dose of ABT-288 |
|
| ABT-288 Dose 2 | Experimental | high dose of ABT-288 |
|
| Sugar Pill | Placebo Comparator | inactive substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-288 Low Dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition: MCCB | Measurements from screening period through 12-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning: UPSA-2 | Measurements from screening period through 12-week treatment period | |
| Cognition: CANTAB | Measurements from screening period through 12-week treatment period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Haig, PharmD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 21662 | Anaheim | California | 92804 | United States | ||
| Site Reference ID/Investigator# 21683 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24516190 | Result | Haig GM, Bain E, Robieson W, Othman AA, Baker J, Lenz RA. A randomized trial of the efficacy and safety of the H3 antagonist ABT-288 in cognitive impairment associated with schizophrenia. Schizophr Bull. 2014 Nov;40(6):1433-42. doi: 10.1093/schbul/sbt240. Epub 2014 Feb 10. | |
| 28433500 | Derived | Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20. |
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inactive substance |
|
| ABT-288 High Dose | Drug |
|
| Symptom Severity: PANSS, NSA-16, CGI-S |
| Measurements from screening period through 12-week treatment period |
| Garden Grove |
| California |
| 92845 |
| United States |
| Site Reference ID/Investigator# 21581 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 45310 | Norwalk | California | 90650 | United States |
| Site Reference ID/Investigator# 26400 | Pasadena | California | 91106 | United States |
| Site Reference ID/Investigator# 21584 | Pico Rivera | California | 90660 | United States |
| Site Reference ID/Investigator# 45312 | Riverside | California | 92506 | United States |
| Site Reference ID/Investigator# 45309 | San Diego | California | 92128 | United States |
| Site Reference ID/Investigator# 46603 | Plantation | Florida | 33317 | United States |
| Site Reference ID/Investigator# 21681 | Chicago | Illinois | 60640 | United States |
| Site Reference ID/Investigator# 26397 | Shreveport | Louisiana | 71104-2136 | United States |
| Site Reference ID/Investigator# 21761 | Pittsfield | Massachusetts | 01201 | United States |
| Site Reference ID/Investigator# 21591 | St Louis | Missouri | 63139 | United States |
| Site Reference ID/Investigator# 26409 | Brooklyn | New York | 11235 | United States |
| Site Reference ID/Investigator# 21588 | Cedarhurst | New York | 11516 | United States |
| Site Reference ID/Investigator# 21589 | Dayton | Ohio | 45417 | United States |
| Site Reference ID/Investigator# 26407 | Oklahoma City | Oklahoma | 73103 | United States |
| Site Reference ID/Investigator# 21601 | Philadelphia | Pennsylvania | 19131 | United States |
| Site Reference ID/Investigator# 26399 | Charleston | South Carolina | 29407 | United States |
| Site Reference ID/Investigator# 21590 | Austin | Texas | 78731 | United States |
| Site Reference ID/Investigator# 21582 | Austin | Texas | 78754 | United States |
| Site Reference ID/Investigator# 26406 | DeSoto | Texas | 75115 | United States |
| Site Reference ID/Investigator# 26402 | Houston | Texas | 77008 | United States |
| Site Reference ID/Investigator# 27502 | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| C576396 | 2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one |
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