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Home > "A" Clinical Trials Conditions > An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder  An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
For Condition: Bipolar Disorder
Status: No longer recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: KEY 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 KEY 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, corticosteriods) - 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
Total Enrollment:
Location and Contact Information:
VAMC
Milwaukee, Wisconsin, 53295
United States
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850
United States
Brentwood Research Inst.
Shreveport, Louisiana, 71101
United States
San Antonio State Hospital
San Antonio, Texas, 78223
United States
McLean Hospital
Belmont, Massachusetts, 02478
United States
UT Mental Sciences Institute
Houston, Texas, 77030
United States
Steven A. Glass, MD
Clementon, New Jersey, 08021
United States
CNS of Northern Virginia
Falls Church, Virginia, 22041
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Mark Lerman, MD
Hoffman Estates, Illinois, 60194
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
University of Louisville Bipolar Research Program
Louisville, Kentucky, 40202
United States
The Holliswood Hospital
Holliswood, New York, 11423
United States
NYU School of Medicine – Bellevue
New York City, New York, 10016
United States
Pioneer Research
Baltimore, Michigan, 48047
United States
AVI Clinical Research
Torrance, California, 90505
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Comprehensive Neuroscience of SCA
Cerritos, California, 90703
United States
Additional Information:
Study ID Numbers: M02-540;
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060905
Other Bipolar Disorder Studies:
1. Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
2. Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression
3. The Evaluation and Follow-up of Patients with Bipolar Disorder
4. Riluzole and Lithium to treat Depression in Bipolar Disorder
5. Clinical Trial of Pramipexole in Bipolar Depression
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Massachusetts Clinical Trials
Other Belmont Clinical Trials
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
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