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The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RG2417 | Experimental | Oral RG2417 taken twice daily for 8 weeks |
|
| Placebo | Placebo Comparator | Oral placebo taken twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG2417 | Drug | 1g bid dose escalates to 2g bid for weeks 2-8. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Score | Baseline and weekly for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-BP-S | Baseline and weekly for 8 weeks | |
| Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score) | Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Sachs, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical Studies, Inc. | Birmingham | Alabama | 35226 | United States | ||
| K&S Professional Research Services |
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| Placebo | Drug | Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. |
|
|
| Little Rock |
| Arkansas |
| 72201 |
| United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Behavioral Clinical Research | North Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solution, Inc. | Orlando | Florida | 32806 | United States |
| University of South Florida College of Medicine | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Valle Vista Health System | Greenwood | Indiana | 46143 | United States |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic Department of Pscyhiatry & Psychology | Rochester | Minnesota | 55905 | United States |
| Behavioral Medical Research of States Island | Staten Island | New York | 10305 | United States |
| Unvieristy of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Richard H. Weisler, MD, PA and Associates | Raleigh | North Carolina | 27609 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oregon Center for Clinical Investigations, Inc. | Portland | Oregon | 97210 | United States |
| Western Psychiatric Institute Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| Lincoln Research | Lincoln | Rhode Island | 02856 | United States |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Vanderbilt University School of Medicine | Nashville | Tennessee | 37212 | United States |
| FutureSearch Trials of Austin | Austin | Texas | 78756 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| University of Texas, Houston Medical Center | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Dean Foundation | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014529 | Uridine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D002241 | Carbohydrates |
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