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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Divalproex Sodium (Depakote ER)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divalproex Sodium (Depakote ER)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder (manic or mixed type)