An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
NCT ID: NCT00060905
Last Updated: 2006-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Divalproex Sodium (Depakote ER)
Eligibility Criteria
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Inclusion Criteria
* Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score \>= 18
* Hospitalized no more than 7 days at time of Screening or in process of being admitted
* History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement
Exclusion Criteria
* Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
* Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
* Had first manic episode after age 60
* Has ever taken clozapine
* Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of active alcohol or substance dependence within past 3 months.
* History of failed treatment on adequate valproate therapy for bipolar disorder
* Has taken Depakote (DR or ER) regularly over the last 30 days
* Has serious violent, homicidal, or suicidal ideation
18 Years
65 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Global Medical Information - Abbott
Role: STUDY_DIRECTOR
Abbott
Locations
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Comprehensive Neuroscience of SCA
Cerritos, California, United States
AVI Clinical Research
Torrance, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Mark Lerman, MD
Hoffman Estates, Illinois, United States
University of Louisville Bipolar Research Program
Louisville, Kentucky, United States
Brentwood Research Inst.
Shreveport, Louisiana, United States
Centers for Behavioral Health, LLC
Rockville, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Pioneer Research
Baltimore, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Steven A. Glass, MD
Clementon, New Jersey, United States
The Holliswood Hospital
Holliswood, New York, United States
NYU School of Medicine - Bellevue
New York, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
UT Mental Sciences Institute
Houston, Texas, United States
San Antonio State Hospital
San Antonio, Texas, United States
CNS of Northern Virginia
Falls Church, Virginia, United States
VAMC
Milwaukee, Wisconsin, United States
Countries
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References
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Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.
Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.
Other Identifiers
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M02-540
Identifier Type: -
Identifier Source: org_study_id