Bipolar Disorder
Conditions
Keywords
Bipolar Disorder (manic or mixed type)
Brief summary
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.
Interventions
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS), | — |
| BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS. | — |
Countries
United States
Outcome results
None listed