An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.

Key facts

Study ID

NCT00060905

Run by

Abbott

People needed

370

Starts

2003-01-01

Last updated by the study team

2006-08-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current primary diagnosis of bipolar I disorder, mania or mixed type
• 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

You may not qualify if…

• History of schizophrenia or schizoaffective disorder
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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