Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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 episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation

Key facts

Study ID

NCT00397020

Run by

University of California, San Diego

People needed

30

Starts

2006-12-01

Expected to finish

2008-12-01

Last updated by the study team

2019-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCSD Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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