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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Slow Progressive Divalproex DR to Divalproex ER switch |
|
| 1 | Active Comparator | Immediate, Progressive Divalproex DR to Divalproex ER switch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex | Drug | Divalproex, 8-20% taper |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects) | Baseline to day +8 |
| Measure | Description | Time Frame |
|---|---|---|
| seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale; | Baseline to day + 8 | |
| total valproic acid serum levels (trough of pre-dose measurements) | Prior to conversion, 1 week post conversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Hellings, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D008607 | Intellectual Disability |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Divalproex |
| Drug |
Divalproex, 8-20% taper |
|
|
| changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel | Prior to and one week post conversion |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |