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Decision based on strategic determination; not safety.
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The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-436 | Experimental | Subject receiving ABT-436 |
|
| Escitalopram | Active Comparator | Subject receiving escitalopram. |
|
| Placebo | Placebo Comparator | Subject receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-436 | Drug | Subjects receiving ABT-436 |
| |
| Escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. | Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. | Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Rendenbach-Mueller, PhD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 85593 | Little Rock | Arkansas | 72211 | United States | ||
| Site Reference ID/Investigator# 87228 |
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| Drug |
Subjects receiving escitalopram |
|
| Placebo | Drug | Subject receiving placebo |
|
| Garden Grove |
| California |
| 92845 |
| United States |
| Site Reference ID/Investigator# 87214 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 87220 | Oakland | California | 94612 | United States |
| Site Reference ID/Investigator# 87215 | Bradenton | Florida | 34201 | United States |
| Site Reference ID/Investigator# 87225 | South Miami | Florida | 33143 | United States |
| Site Reference ID/Investigator# 85594 | Atlanta | Georgia | 30328 | United States |
| Site Reference ID/Investigator# 85580 | Marlton | New Jersey | 08053 | United States |
| Site Reference ID/Investigator# 87227 | Brooklyn | New York | 11235 | United States |
| Site Reference ID/Investigator# 87223 | New York | New York | 10128 | United States |
| Site Reference ID/Investigator# 87217 | Dayton | Ohio | 45417 | United States |
| Site Reference ID/Investigator# 87226 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 87221 | Philadelphia | Pennsylvania | 19139 | United States |
| Site Reference ID/Investigator# 87219 | Austin | Texas | 78731 | United States |
| Site Reference ID/Investigator# 87216 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 87933 | Houston | Texas | 77008 | United States |
| Site Reference ID/Investigator# 88874 | Salt Lake City | Utah | 84106 | United States |
| Site Reference ID/Investigator# 88876 | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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