An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Launched by ABBOTT · May 15, 2003
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • INCLUSION CRITERIA
- • 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
- • EXCLUSION CRITERIA
- • 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
About Abbott
Abbott is a global healthcare company dedicated to improving lives through innovative medical technologies, diagnostics, nutrition, and branded generic pharmaceuticals. With a commitment to advancing health and wellness, Abbott conducts clinical trials to evaluate the safety and efficacy of its diverse portfolio of products, which span multiple therapeutic areas, including cardiovascular, diabetes care, and neurology. The company employs rigorous research methodologies and collaborates with healthcare professionals and institutions worldwide to ensure the highest standards of clinical integrity and patient safety. Abbott's mission is to deliver impactful solutions that enhance patient outcomes and contribute to the advancement of global healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jackson, Mississippi, United States
Cleveland, Ohio, United States
Jackson, Mississippi, United States
Washington, District Of Columbia, United States
Belmont, Massachusetts, United States
Rockville, Maryland, United States
Cerritos, California, United States
Torrance, California, United States
Hoffman Estates, Illinois, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Michigan, United States
Clementon, New Jersey, United States
Holliswood, New York, United States
New York, New York, United States
Houston, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Milwaukee, Wisconsin, United States
Patients applied
Trial Officials
Global Medical Information - Abbott
Study Director
Abbott
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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