Status:
COMPLETED
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Abbott
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute ...
Detailed Description
This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty...
Eligibility Criteria
Inclusion
- For inclusion, patients must fulfill all of the following criteria at enrollment:
- Provide written informed consent before initiation of any study-related procedures
- A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Mixed (296.5x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSMIV)
- Male or female, at least 18 years old
- YMRS score equal to or greater than 17 and a CGI of 4 (moderate) or greater.
- Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.
Exclusion
- Known intolerance or lack of response to quetiapine fumarate or Divalproex ER as judged by the investigator.
- Unwilling or not able to provide informed consent
- Positive urine toxicology result on screening for cocaine, phencyclidine (PCP), opiates or amphetamines that confirms the current manic/mixed episode is better accounted by a substance intoxication or withdrawal as judged by PI.
- History of schizophrenia or schizoaffective disorder
- Treatment with a depot antipsychotic within 1 treatment cycle
- Unstable medical condition including hepatic, renal, gastroenterologic, neurologic, immunologic, or hematologic diseases that is deemed by the principle investigator to likely to result in hospitalization in 6 months or death within one year
- A female subject who is pregnant or lactating
- Lorazepam will be provided for agitation and insomnia as needed for rescue only. Not to exceed 6 mg in the first 7 days; Not to exceed 4 mg for the next 3 days and note to exceed 2 mg/day for the remainder of the study. Those that require a greater amount of Lorazepam will be excluded.
- Hospitalized for more than 1 week for current episode at the screen
- Substance or alcohol dependence at enrollment and within the three months prior to enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
- Known diagnosis of dementia or MCI
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00397020
Start Date
December 1 2006
End Date
December 1 2008
Last Update
September 11 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSD Medical Center
San Diego, California, United States, 92103