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

Abbott

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Divalproex Sodium (Depakote ER)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00060905

M02-540

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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