Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203528
Status:
COMPLETED
Last Update Posted:
2007-03-19
First Post:
2005-09-12
Brief Title:
Divalproex ER vs Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Divalproex ER vs Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
Status:
COMPLETED
Status Verified Date:
2007-03
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 primary objective is to evaluate the safety and efficacy of divalproex extended release ER compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder
Detailed Description:
Patients will be screened up to seven days at which time the following assessments will be completed the Structured Clinical Interview for DSM-IV SCID general medical history psychiatric history physical examination physicians assessment and laboratory tests Patients who are on mood stabilizers and oral neuroleptics prior to study enrollment and are not responding fully to these medications will be tapered off of the medication for a washout period of 48 hours After the completion of screening only patients who are determined to be eligible for the study will be randomized to study medication divalproex or risperidone in a 11 double-blind fashion Scheduled study visits will occur every two weeks for a total of 12 weeks Assessments for each visit from the baseline visit to the week 12 visit are as follows the Clinical Global Impression CGI Global Assessment of Functioning GAF Alcohol and Drug Use Inventory clinician alcohol and drug use scales self report scales adverse events vital signs and weight concomitant medications urine drug screen and study medication accountability Designated research staff will complete assessments weekly Investigators will be blinded to laboratory tests completed at week 2 4 and 12 visits Patients randomized to Depakote ER will begin 500mg BID on day of randomization and remain on this dose for 5 days then on day 6 increase to 20mgkg to achieve valproic acid levels of 80-100 blinded laboratory reporting Patients randomized to risperidone initially start with 2mg QD with an increase to 4mg at day 5 and increase as tolerated or required up to 6mgd
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TREAC Dual Diagnosis Study | None | None | None |