Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211250
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2005-09-13
Brief Title:
Comparing Compliance Tolerability Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER
Sponsor:
Joliet Center for Clinical Research
Organization:
Joliet Center for Clinical Research
Study Overview
Official Title:
An Exploratory Study Comparing Compliance Tolerability Efficacy and Adverse Events in Bipolar I and II Patients From Valproic Acid to Depakote ER
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare compliance tolerability effectiveness and side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER
Detailed Description:
Over the next year between 20 and 40 patients who meet all inclusion and exclusion criteria will be entered into the study The treatment period of the study will last at least 10-13 weeks depending on how quickly your Depakote ER level reaches a therapeutic level 50-100mcgmL
At your first visit
A medical and psychiatric history will be obtained For your own safety it is your responsibility to tell the study doctor or study staff of your past and present diseases all allergies and medical conditions and all medications that you currently or recently have taken including over-the-counter medications such as vitamins allergy medicines and herbal drugs A physical examination and vital signs which will include measuring your height weight blood pressure respiratory breathing rate and heart rate pulse
Blood samples will be taken through a needle in your vein Approximately 2-2 ½ tablespoons 28 or 38 ml of blood for routine testing of hematology red and white blood cells and clinical chemistry blood salt sugar fats and hormones and tests of liver kidney and thyroid function and valproate level
A urinalysis a urine pregnancy test for all females and a urine drug screen will be obtained If you are a woman and your urine pregnancy test is positive a blood test will be done to confirm this you will not be able to participate in this study if this is also positive
An electrocardiogram ECG - a painless electrical tracing of your heart function
Psychiatric scales designed to measure past compliance side-effects and your bipolar symptoms will be administered See the Attached Schedule of Events for a list of all Procedures required during the study Patients who continue to meet all inclusion and exclusion criteria will return for a baseline visit Visit 2 At this visit you will discontinue valproic acid and begin taking Depakote ER the following day The total daily dose will be adjusted to be 8-20 higher than your original valproic acid dose at the discretion of the Investigator in order to reach therapeutic levels Rating scales will be administered and the study drug Depakote ER will be dispensed
Your study doctor or staff will explain the amount of medication you will receive and will give you instructions on how to take it It is important that your study drug is not taken by anyone else Your study doctor and other study staff whom you are to ask any questions about the study drugs effects and any side effects will regularly check your response to treatment If you get worse the study drug dose may be changed or you may be given additional medications or the study drug may be stopped and you will be given another drug instead
Before continuing to visit 3 you must reach a valproate level of 50-100mcgmL Weekly titration visits T1-T4 will be scheduled and blood samples will be taken to test the Valproic level in your blood The study doctor may adjust your dose until a level of 50-100 mcgml is reached If the above level is not reached within four weeks of visit 2 you will be discontinued from the study
After the therapeutic level is reached you will be asked to return in one week for visit 3 four weeks for visit 4 and another four weeks for the final visit visit 5 Overall your treatment with Depakote ER will be between 10-13 weeks in duration During visits 3 and 4 the Depakote ER dose may be adjusted in 250mg or 500mg increments to maintain adequate level to manage side effects andor manage bipolar symptoms at the discretion of the study doctor In addition you will be asked to report any side effects and complete the psychiatric scales at each visit and blood samples will be taken at visits 3 and 5 See the Schedule of Events for more details
At your first visit
A medical and psychiatric history will be obtained For your own safety it is your responsibility to tell the study doctor or study staff of your past and present diseases all allergies and medical conditions and all medications that you currently or recently have taken including over-the-counter medications such as vitamins allergy medicines and herbal drugs A physical examination and vital signs which will include measuring your height weight blood pressure respiratory breathing rate and heart rate pulse
Blood samples will be taken through a needle in your vein Approximately 2-2 ½ tablespoons 28 or 38 ml of blood for routine testing of hematology red and white blood cells and clinical chemistry blood salt sugar fats and hormones and tests of liver kidney and thyroid function and valproate level
A urinalysis a urine pregnancy test for all females and a urine drug screen will be obtained If you are a woman and your urine pregnancy test is positive a blood test will be done to confirm this you will not be able to participate in this study if this is also positive
An electrocardiogram ECG - a painless electrical tracing of your heart function
Psychiatric scales designed to measure past compliance side-effects and your bipolar symptoms will be administered See the Attached Schedule of Events for a list of all Procedures required during the study Patients who continue to meet all inclusion and exclusion criteria will return for a baseline visit Visit 2 At this visit you will discontinue valproic acid and begin taking Depakote ER the following day The total daily dose will be adjusted to be 8-20 higher than your original valproic acid dose at the discretion of the Investigator in order to reach therapeutic levels Rating scales will be administered and the study drug Depakote ER will be dispensed
Your study doctor or staff will explain the amount of medication you will receive and will give you instructions on how to take it It is important that your study drug is not taken by anyone else Your study doctor and other study staff whom you are to ask any questions about the study drugs effects and any side effects will regularly check your response to treatment If you get worse the study drug dose may be changed or you may be given additional medications or the study drug may be stopped and you will be given another drug instead
Before continuing to visit 3 you must reach a valproate level of 50-100mcgmL Weekly titration visits T1-T4 will be scheduled and blood samples will be taken to test the Valproic level in your blood The study doctor may adjust your dose until a level of 50-100 mcgml is reached If the above level is not reached within four weeks of visit 2 you will be discontinued from the study
After the therapeutic level is reached you will be asked to return in one week for visit 3 four weeks for visit 4 and another four weeks for the final visit visit 5 Overall your treatment with Depakote ER will be between 10-13 weeks in duration During visits 3 and 4 the Depakote ER dose may be adjusted in 250mg or 500mg increments to maintain adequate level to manage side effects andor manage bipolar symptoms at the discretion of the study doctor In addition you will be asked to report any side effects and complete the psychiatric scales at each visit and blood samples will be taken at visits 3 and 5 See the Schedule of Events for more details
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None