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| ID | Type | Description | Link |
|---|---|---|---|
| RRA-12001, EVT 101/1012 | Other Identifier | Janssen Research & Development, LLC |
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Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| EVT 101 | Experimental | EVT 101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVT 101 | Drug | HPMC Capsule, 15 mg, once daily for 28 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Profile of EVT 101 | AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires | 28 days of EVT 101-Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of EVT 101 in depression measured using the MADRS score | Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline | 28 days |
| Percentage of patients who respond to treatment with study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Greiling, PhD | Evotec AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evotec Study Site 6 | Oceanside | California | United States | |||
| Evotec Study Site 19 |
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| Drug |
HPMC Placebo capsules, once daily for 28 days |
|
| 4 weeks |
| Percentage of patients who experience remission | 4 weeks |
| San Diego |
| California |
| United States |
| Evotec Study Site 15 | Tampa | Florida | United States |
| Evotec Study Site 4 | Atlanta | Georgia | United States |
| Evotec Study Site 14 | Smyrna | Georgia | United States |
| Evotec Study Site 3 | Beachwood | Illinois | United States |
| Evotec Study Site 2 | Oak Brook | Illinois | United States |
| Evotec Study Site 1 | Baltimore | Maryland | United States |
| Evotec Study Site 8 | Flowood | Mississippi | United States |
| Evotec Study Site 5 | Willingboro | New Jersey | United States |
| Evotec Study Site 9 | New York | New York | United States |
| Evotec Study Site 13 | Oklahoma City | Oklahoma | United States |
| Evotec Study Site 7 | Dallas | Texas | United States |
| Evotec Study Site 12 | Houston | Texas | United States |
| ID | Term |
|---|---|
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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