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The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium (Depakote ER) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
| Measure | Description | Time Frame |
|---|---|---|
| Y-MRS | ||
| CGI-S | ||
| C-GAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PCSD Feighner Research | San Diego | California | 92111 | United States | ||
| PCSD Feighner Research |
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| CDRS-R |
| CGSQ |
| responders |
| remitters |
| San Marcos |
| California |
| 92078 |
| United States |
| Altamonte Springs | Florida | 32701 | United States |
| Segal Institute for Clinical Research | Fort Lauderdale | Florida | 33319 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Kolin Research Group | Winter Park | Florida | 32789 | United States |
| Northlake Medical Research Center | Decatur | Georgia | 30033 | United States |
| Mountain West Clinical Trials | Eagle | Idaho | 83616 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Clinco | Terre Haute | Indiana | 47802 | United States |
| Cientifica Inc. | Newton | Kansas | 67114 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Brentwood Research Institute | Shreveport | Louisiana | 71101 | United States |
| Acadia Hospital | Bangor | Maine | 04402-0422 | United States |
| Pharmasite Research | Baltimore | Maryland | 21208 | United States |
| North Carolina Neuropsychiatry, PA | Chapel Hill | North Carolina | 27514 | United States |
| Odyssey Research | Fargo | North Dakota | 58104 | United States |
| Neuro Behavioral Clinical Research, INC. | Canton | Ohio | 44708 | United States |
| Psychiatric Professional Services | Cincinnati | Ohio | 45267-0559 | United States |
| Rakesh Ranjan, M.D. & Associates, Inc. | Lyndhurst | Ohio | 44124 | United States |
| IPS Research | Oklahoma City | Oklahoma | 73103 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| Clinical Trials Specialists | Bala-Cynwyd | Pennsylvania | 19004-1604 | United States |
| UTHSC, Sept. of Psychiatry, College of Medicine | Memphis | Tennessee | 38105 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Red Oak Psychiatry | Houston | Texas | 77090 | United States |
| R/D Clinical Research | Lake Jackson | Texas | 77566 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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